SmokingPhase 4CessationNCT01116986

Identifying Optimal Smoking Cessation Intervention Components (Cessation)

A Phase 4 study testing Counseling before quit attempt, Minimal In-person counseling during quit attempt and Intensive in-person counseling during the quit attempt in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Smoking, Smoking Cessation, Nicotine Dependence
What is being tested?: Counseling before quit attempt, Minimal In-person counseling during quit attempt and Intensive in-person counseling during the quit attempt
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 637 participants
Where: 1 siteUnited States
Study dates: Jun 2010to May 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older;
Report smoking at least 5 cigarettes per day for the previous 6 months;
Able to read and write English;
Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
Plans to remain in the intervention catchment area for at least 12 months;
Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.

Who cannot join

Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
Study candidate is pregnant, trying to get pregnant, or nursing.
A history of psychosis or bipolar disorder
A history of skin or allergic reactions while using a nicotine patch.
Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711

Other trials in United States

About this study

Official title: Project 2: Identifying Optimal Smoking Cessation Intervention Components

The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.

Conditions: Smoking, Smoking Cessation, Nicotine Dependence
Being tested: Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive in-person counseling during the quit attempt, Minimal phone counseling during the quit attempt, Intensive phone counseling during the quit attempt
Keywords: Smoking, Smoking Cessation, Nicotine
Medical subject headings: Smoking, Smoking Cessation, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Counseling before quit attemptBehavioural
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attemptBehavioural
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive in-person counseling during the quit attemptBehavioural
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attemptBehavioural
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Intensive phone counseling during the quit attemptBehavioural
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit AttemptDrug
If randomized to this condition:
After the target quit day:
Patch:
IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Short Term Nicotine Patch + Nicotine Gum during the quit attemptDrug
If randomized to this condition:
After the target quit day:
Patch:
IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine GumDrug
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
Pre-Quit Nicotine PatchDrug
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumDrug
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.

Study groups in NCT01116986
Study group	Role	What they receive
1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk	Experimental	How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum
23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum
24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16	Experimental	This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt Receives: Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

What is being measured

The primary outcome is the main question the study is designed to answer.

Self-Reported 7-Day Point-Prevalence Abstinence
Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.
Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome.
Measured: 16 weeks post-quit

Secondary outcomes (1)

Latency to Relapse
Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.
Measured: During the first 6 months post-quit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010May 2014

First posted5 May 2010 (estimated)
Study startJun 2010
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 637 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01116986
Sponsor's protocol ID: H-2009-0204
Other IDs: 9P50CA143188
Acronym: Cessation
Status last verified: Nov 2015
First submitted: 27 Apr 2010
Last updated: 11 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
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All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project 2: Identifying Optimal Smoking Cessation Intervention Components
ClinicalTrials.gov ID: NCT01116986
Acronym / sponsor ID: Cessation / H-2009-0204
Conditions: Smoking, Smoking Cessation, Nicotine Dependence
Keywords: Smoking, Smoking Cessation, Nicotine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 637 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: Dean Health System, Mercy Health System, Wake Forest University Health Sciences, National Cancer Institute (NCI)
Study start: Jun 2010
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 5 May 2010 (estimated)
Results: Posted 17 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 32

Arm	Type	Receives
1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine PatchThis arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine GumHow effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt, Drug: Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt, Drug: Pre-Quit Nicotine GumThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit AttemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit AttemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk	Experimental	Behavioral: Counseling before quit attempt, Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit AttemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W	Experimental	Behavioral: Minimal In-person counseling during quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Minimal phone counseling during the quit attempt, Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16	Experimental	Behavioral: Intensive in-person counseling during the quit attempt, Behavioral: Intensive phone counseling during the quit attempt, Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit AttemptThis arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

18 years of age or older;
Report smoking at least 5 cigarettes per day for the previous 6 months;
Able to read and write English;
Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
Plans to remain in the intervention catchment area for at least 12 months;

Key exclusion criteria (5 listed)

Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
Study candidate is pregnant, trying to get pregnant, or nursing.
A history of psychosis or bipolar disorder
A history of skin or allergic reactions while using a nicotine patch.
Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Counseling before quit attemptParticipants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.	Behavioural	1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk, 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk, 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk, 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk, 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk, 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk, 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk, 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk, 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk, 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk, 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk, 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk, 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk, 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk, 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk, 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
Minimal In-person counseling during quit attemptParticipants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)	Behavioural	1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk, 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk, 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk, 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk, 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk, 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk, 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk, 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16, 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W, 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk, 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk, 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
Intensive in-person counseling during the quit attemptParticipants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.	Behavioural	11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk, 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk, 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk, 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk, 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk, 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk, 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk, 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk, 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk, 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W, 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16, 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk, 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk, 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk
Minimal phone counseling during the quit attemptParticipants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.	Behavioural	1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk, 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk, 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk, 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk, 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk, 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk, 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16, 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk, 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W, 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk, 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk, 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
Intensive phone counseling during the quit attemptParticipants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.	Behavioural	10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk, 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk, 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk, 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk, 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk, 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk, 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk, 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk, 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk, 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W, 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16, 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk, 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk, 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk
Long Term Nicotine Patch+ Nicotine Gum During Quit AttemptIf randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.	Drug	12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk, 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk, 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk, 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk, 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk, 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk, 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16, 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk, 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16, 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk, 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk, 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
Short Term Nicotine Patch + Nicotine Gum during the quit attemptIf randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.	Drug	1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk, 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk, 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk, 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk, 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk, 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk, 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk, 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk, 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk, 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W, 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W, 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk, 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk, 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk
Pre-Quit Nicotine GumIf randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.	Drug	17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk, 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk, 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk, 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk, 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk
Pre-Quit Nicotine PatchIf randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.	Drug	10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk, 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk, 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk, 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk, 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk, 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk, 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk, 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
Pre-Quit Nicotine Patch + Pre-Quit Nicotine GumIf randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.	Drug	1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk, 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk, 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk, 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk, 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk, 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk, 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk, 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk

Primary outcome

Self-Reported 7-Day Point-Prevalence Abstinence
Time frame: 16 weeks post-quit
Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome.

1 secondary outcome

Latency to Relapse
Time frame: During the first 6 months post-quit

Results and safety

Results posted to the registry on 17 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk	24	22
2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk	19	16
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk	18	16
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk	22	20
5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk	24	20
6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk	22	20
7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk	22	20
8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk	22	20
9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk	20	19
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk	23	19
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk	19	18
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk	20	20
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk	17	16
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk	19	16
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk	17	17
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk	21	15
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk	16	13
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk	24	19
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk	23	20
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk	15	13
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk	24	22
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk	20	18
23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk	23	19
24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk	21	19
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk	18	15
26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk	19	19
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk	18	14
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk	19	18
29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16	17	17
30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W	17	17
31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W	17	16
32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16	17	14

Primary outcome: Self-Reported 7-Day Point-Prevalence Abstinence

Time frame: 16 weeks post-quit. Number. Unit: participants

Measure	No Pre-Quit Nicotine Patch n = 308	Pre-Quit Nicotine Patch n = 329	No Pre-Quit Nicotine Gum n = 298	Pre-Quit Nicotine Gum n = 339	No Counseling Before the Quit Attempt n = 320	Counseling Before the Quit Attempt n = 317	Minimal In-person Counseling During the Quit Attempt n = 323	Intensive In-person Counseling During the Quit Attempt n = 314	Minimal Phone Counseling During the Quit Attemp n = 317	Intensive Phone Counseling During the Quit Attempt n = 320	Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum n = 333	Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum n = 304
# Participants Who Were Smoking	208	209	201	216	221	196	217	200	211	206	223	194
# Participants Who Were Abstinent	100	120	97	123	99	121	106	114	106	114	110	110

No Pre-Quit Nicotine Patch vs Pre-Quit Nicotine Patch: Odds Ratio (OR): 1.087 (95% CI .916 to 1.290), p = .341, Regression, Logistic
No Pre-Quit Nicotine Gum vs Pre-Quit Nicotine Gum: Odds Ratio (OR): 1.117 (95% CI .941 to 1.325), p = .207, Regression, Logistic
No Counseling Before the Quit Attempt vs Counseling Before the Quit Attempt: Odds Ratio (OR): 1.196 (95% CI 1.008 to 1.420), p = .041, Regression, Logistic

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch	1 of 173 (0.6%)	32 of 173 (18.5%)	Not reported
Pre-Quit Nicotine Patch	1 of 156 (0.6%)	27 of 156 (17.3%)	Not reported
Pre-Quit Nicotine Gum	0 of 166 (0%)	22 of 166 (13.3%)	Not reported
No Pre-Quit Nicotine Patch Nor Gum	0 of 142 (0%)	0 of 142 (0%)	Not reported
Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum	5 of 333 (1.5%)	51 of 304 (16.8%)	Not reported
Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum	2 of 304 (0.7%)	55 of 333 (16.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public HealthLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Megan E Piper, PhD study director

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Timothy B Baker, PhD principal investigator

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Reported 7-Day Point-Prevalence Abstinence (time frame: 16 weeks post-quit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.