AzTrials
AzTrials

SmokingPhase 4AdherenceNCT01120704

Evaluation of Treatments to Improve Smoking Cessation Medication Adherence

A Phase 4 study testing Short Term Combination Nicotine Replacement Therapy (patch + gum), Long Term Combination Nicotine Replacement Therapy (patch + gum) and Intensive Maintenance Counseling 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
Search all trials

Trial summary

Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Smoking, Smoking Cessation, Adherence
What is being tested?
Short Term Combination Nicotine Replacement Therapy (patch + gum), Long Term Combination Nicotine Replacement Therapy (patch + gum) and Intensive Maintenance Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
544 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 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications

Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.

Read the detailed description

Nonadherent use of smoking cessation medications is very common and highly associated with cessation failure. However, little is presently known about how to improve adherence and whether improved adherence will actually boost cessation success (i.e., its causal role is unknown). This research represents groundbreaking integration of 1) basic theory and data on tobacco dependence, adherence, and intervention mechanisms with 2) the state-of-the-art Intervention Optimization Cycle methodology. This methodology uses factorial designs to efficiently engineer and evaluate intervention components, and to develop an optimal comprehensive treatment package. Participants in Project 3 will be smokers (N = 544) visiting primary care clinics for a regular outpatient visit who, when asked, express an interest in quitting and agree to participate in a smoking cessation research study. The experiment will comprise five experimental factors (2X2X2X2X2), and participants will have a 50% chance of being assigned one of the levels of each factor. The five factors include one medication factor (medication duration: 8 vs. 26 weeks), one counseling factor (maintenance counseling vs. no maintenance counseling), and three adherence factors: 1) Cognitive Medication Adherence Counseling (C-MAC); C-MAC vs. no C-MAC; 2) electronic medication monitoring device (the Helping Hand) + Feedback vs. the medication monitoring device alone; and 3) automated adherence prompting phone calls vs. no prompting.

Being tested
Short Term Combination Nicotine Replacement Therapy (patch + gum), Long Term Combination Nicotine Replacement Therapy (patch + gum), Intensive Maintenance Counseling, Cognitive Medication Adherence Counseling (CAM), Electronic Medication Monitoring Device (the Helping Hand) + Feedback
Keywords
Smoking, Smoking Cessation, Adherence, Nicotine, Motivation
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.

  • Short Term Combination Nicotine Replacement Therapy (patch + gum)Drug

    IF participant smokes >10 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.

    IF participant smokes 5-10 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.

  • Long Term Combination Nicotine Replacement Therapy (patch + gum)Drug

    IF the participant smokes >10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.

    IF the participant smokes 5-10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.

  • Intensive Maintenance CounselingBehavioural

    Participants randomized to this condition will receive eight 15-minute phone counseling sessions at Weeks 3, 4, 6, 8, 10, 14, 18 \& 22. The counseling will encourage continued practice of coping skills, and avoidance of danger situations. Another emphasis will be the continued provision of social support as a means of enhancing motivation. Participants who have relapsed will receive counseling aimed at motivating and planning renewed quit attempts. Other aims are enhancing motivation, especially competence self-appraisals, providing intratreatment support, and encouraging pleasurable activities.

  • Cognitive Medication Adherence Counseling (CAM)Behavioural

    Participants randomized to this condition will be given a brief (10 minute) session of CAM treatment at both Visits 1 and 2. CAM will include information on NRT such as the following: NRT reduces withdrawal and urges; sustained use reduces the likelihood of relapse; willpower and medication make a good combination; NRT will help a lapsing smoker reachieve abstinence. The tailored counseling component of the CAM intervention is based on brief evaluation of the smoker's beliefs, concerns, and possible misconceptions about smoking cessation medications.

  • Electronic Medication Monitoring Device (the Helping Hand) + FeedbackBehavioural

    If randomized to this condition, the case manager will give patients a computer-generated feedback sheet showing the patient's medication self-administration since the last visit. The case manager will provide problem-solving counseling regarding barriers to medication use. This problem-solving counseling intervention will be given in brief in-person sessions (three in-person sessions for those in the 8 week medication condition and five in-person sessions for those in the 26 week medication condition). Medication monitoring counseling will also occur via phone (two 10-minute sessions for those in the 8 week medication condition and four 10-minute sessions for those in the 26 week medication condition).

  • Automated Adherence Prompting Phone CallsBehavioural

    Participants in this condition will receive fully automated prompts with messages designed to encourage participants to take their medication.

    Adherence prompting calls will occur two times in the first week of the quit attempt, and then once a week in weeks 2, 3, 4, 5, and 7. Those in the 26-Week medication condition who are assigned to the active adherence prompting calls intervention, will receive one prompting call a week during Weeks 11, 15, 19 \& 23.

Study groups in NCT01120704
Study groupRoleWhat they receive
1, 26Wks, Counseling, CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
2, 26Wks, Counseling, CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Automated Adherence Prompting Phone Calls
3, 26Wks, Counseling, CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
4, 26Wks, Counseling, CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM)
5, 26Wks, Counseling, No CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
6, 26Wks, Counseling, No CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Automated Adherence Prompting Phone Calls
7, 26Wks, Counseling, No CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
8, 26Wks, Counseling, No CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling
9, 26Wks, No Counseling, CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
10, 26Wks, No Counseling, CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Automated Adherence Prompting Phone Calls
11, 26Wks, No Counseling, CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
12, 26Wks, No Counseling, CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM)
13, 26Wks, No Counseling, No CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
14, 26Wks, No Counseling, No CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Automated Adherence Prompting Phone Calls
15, 26Wks, No Counseling, No CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
16, 26Wks, No Counseling, No CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
17, 8Wks, Counseling, CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
18, 8Wks, Counseling, CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Automated Adherence Prompting Phone Calls
19, 8Wks, Counseling, CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
20, 8Wks, Counseling, CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Cognitive Medication Adherence Counseling (CAM)
21, 8Wks, Counseling, No CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
22, 8Wks, Counseling, No CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Automated Adherence Prompting Phone Calls
23, 8Wks, Counseling, No CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling; Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
24, 8Wks, Counseling, No CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Intensive Maintenance Counseling
25, 8Wks, No Counseling, CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
26, 8Wks, No Counseling, CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Automated Adherence Prompting Phone Calls
27, 8Wks, No Counseling, CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
28, 8Wks, No Counseling, CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Cognitive Medication Adherence Counseling (CAM)
29, 8Wks, No Counseling, No CAM, AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Behavioral: Automated Adherence Prompting Phone Calls
30, 8Wks, No Counseling, No CAM, AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Automated Adherence Prompting Phone Calls
31, 8Wks, No Counseling, No CAM, No AutoCalls, FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum); Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback
32, 8Wks, No Counseling, No CAM, No AutoCalls, No FeedbackExperimentalThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Receives: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)

What is being measured

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

  1. 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 (52 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 52 Self-Reported 7-Day Point-Prevalence Abstinence.

    Measured: Assessed at 52 weeks after target quit day

Secondary outcomes (1)

  1. Latency to Relapse

    Latency to Relapse during the first 12 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: Assessed during the first 12 months post-quit after target quit day

Timeline

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

  1. First posted11 May 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

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
544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120704
Sponsor's protocol ID
H-2010-0049
Other IDs
9P50CA143188
Acronym
Adherence
Status last verified
Nov 2015
First submitted
3 May 2010
Last updated
11 Dec 2015
Data monitoring committee
Yes

Publications

  • McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Baker TB. Psychological mediators of bupropion sustained-release treatment for smoking cessation. Addiction. 2008 Sep;103(9):1521-33. doi: 10.1111/j.1360-0443.2008.02275.x.

    PubMed 18783504

  • Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

    PubMed 37335995

  • Schlam TR, Baker TB, Smith SS, Bolt DM, McCarthy DE, Cook JW, Hayes-Birchler T, Fiore MC, Piper ME. Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse. Nicotine Tob Res. 2020 Oct 29;22(11):2051-2058. doi: 10.1093/ntr/ntaa116.

    PubMed 32598468

  • Schlam TR, Cook JW, Baker TB, Hayes-Birchler T, Bolt DM, Smith SS, Fiore MC, Piper ME. Can we increase smokers' adherence to nicotine replacement therapy and does this help them quit? Psychopharmacology (Berl). 2018 Jul;235(7):2065-2075. doi: 10.1007/s00213-018-4903-y. Epub 2018 Apr 25.

    PubMed 29696311

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Short Term Combination Nicotine Replacement Therapy (patch + gum), Long Term Combination Nicotine Replacement Therapy (patch + gum) and Intensive Maintenance Counseling in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.

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 16 Feb 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: Assessed at 52 weeks after target quit day). 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 NCT01120704, which also lists 4 linked publications.

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.

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