SmokingPhase 4NCT01087905

Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

A Phase 4 study testing Nicotine patch, Nicotine gum and CMAC in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 2 sites 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 years and older
Conditions the study is for: Smoking, Smoking Cessation
What is being tested?: Nicotine patch, Nicotine gum and CMAC
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 987 participants
Where: 2 sitesUnited States
Study dates: Apr 2010to Nov 2011
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Callers will be eligible to participate in the study if they are English speaking; are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are interested in quitting and are willing to set a quit date; willing and able to use nicotine patch and nicotine gum; agree to receive four follow-up counseling calls from Free \& Clear (the quitline vendor for the State of Wisconsin); provide verbal informed consent; and provide contact information and agree to take four study follow-up calls from staff at the University of Wisconsin Center for Tobacco Research and Intervention.

Who cannot join

Callers will be excluded if they are under the age of 18; are pregnant or breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are unwilling or unable to use study NRT medications; are currently using a cessation medication (NRT, bupropion, varenicline); or have medical exclusions as per FDA-approved product labeling.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Wisconsin Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
Seattle, Washington, 98104

Other trials in United States

About this study

Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.

Read the detailed description

The study design is a fully crossed 2x2x2 factorial design that tested the effect of two versus six weeks of nicotine replacement therapy (NRT), the effect of NRT monotherapy (nicotine patch alone) versus NRT combination therapy (nicotine patch + oral NRT), and the effect of cognitive medication adherence counseling (CMAC) versus no CMAC. A total of 987 smokers seeking cessation assistance from the Wisconsin Tobacco Quit Line (WTQL) were randomly assigned to the eight (2x2x2) different conditions generated by the three experimental factors. This design provides us with sufficient power to analyze each of our three main effects listed above. We will also test for two- and three-way interactions, but do not have sufficient data to make a priori assumptions about interaction effects. Finally, we will conduct a cost-effectiveness analysis for each of the three interventions to allow readers of this research to evaluate whether the additional costs of the interventions yield sufficient gains to warrant implementing them broadly.

Conditions: Smoking, Smoking Cessation
Being tested: Nicotine patch, Nicotine gum, CMAC
Keywords: Smoking, Smoking cessation, Medication adherence
Medical subject headings: Smoking, Smoking Cessation, Medication Adherence

What participants receive

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

Nicotine patchDrug
If > 10 cigs/day: one 21 mg nicotine patch per day
If < or = 10 cigs/day: one 14 mg nicotine patch per day
Nicotine gumDrug
Also called Nicotine polacrilex
If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
CMACBehavioural
Also called Cognitive Medication Adherence Counseling
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.

Study groups in NCT01087905
Study group	Role	What they receive
2 Weeks of Nicotine Patch Only, No CMAC	Active comparator	Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks Receives: Drug: Nicotine patch
2 Weeks of Nicotine Patch Only plus CMAC	Active comparator	Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks Receives: Drug: Nicotine patch; Behavioral: CMAC
2 Wks Nicotine Patch+Nic Gum, No CMAC	Active comparator	Participants in this randomization arm received 2 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. Receives: Drug: Nicotine patch; Drug: Nicotine gum
2 Wks Nicotine Patch+Nic Gum plus CMAC	Active comparator	Participants in this randomization arm received 2 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. Receives: Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: CMAC
6 Weeks of Nicotine Patch Only, No CMAC	Active comparator	Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks Receives: Drug: Nicotine patch
6 Weeks of Nicotine Patch Only plus CMAC	Active comparator	Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks Receives: Drug: Nicotine patch; Behavioral: CMAC
6 Wks Nicotine Patch+Nic Gum, No CMAC	Active comparator	Participants in this randomization arm received 6 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. Receives: Drug: Nicotine patch; Drug: Nicotine gum
6 Wks Nicotine Patch+Nic Gum plus CMAC	Active comparator	Participants in this randomization arm received 6 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. Receives: Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: CMAC

What is being measured

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

7-Day Point Prevalence Abstinence From Smoking by Intervention
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
Measured: 26 weeks after the target quit smoking date
7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
Measured: 26 weeks after the target quit smoking date

Secondary outcomes (1)

Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.
Measured: 26 weeks after the target quit smoking date

Timeline

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

Apr 2010Nov 2011

First posted16 Mar 2010 (estimated)
Study startApr 2010
Primary completionFeb 2011
Study completionNov 2011

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.
Publications (1)Papers the sponsor has linked to this study.
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: 987 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01087905
Sponsor's protocol ID: H2009-0074
Other IDs: 1RC1CA144382-01
Status last verified: Oct 2016
First submitted: 15 Mar 2010
Last updated: 8 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Upon request, clinical trial data will be shared with other investigators in the form of de-identified datasets. Requests can be sent to Stevens S. Smith, Ph.D., at sss@ctri.wisc.edu

Publications

Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res. 2013 Mar;15(3):718-28. doi: 10.1093/ntr/nts186. Epub 2012 Sep 19.
PubMed 22992296

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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Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
ClinicalTrials.gov ID: NCT01087905
Acronym / sponsor ID: H2009-0074
Conditions: Smoking, Smoking Cessation
Keywords: Smoking, Smoking cessation, Medication adherence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 987 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: Wisconsin Department of Health and Family Services, Consumer Wellness Solutions, Department of Health and Human Services, National Cancer Institute (NCI)
Study start: Apr 2010
Primary completion: Feb 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 16 Mar 2010 (estimated)
Results: Posted 24 Apr 2013

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 8

Arm	Type	Receives
2 Weeks of Nicotine Patch Only, No CMAC	Active comparator	Drug: Nicotine patchParticipants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks
2 Weeks of Nicotine Patch Only plus CMAC	Active comparator	Drug: Nicotine patch, Behavioral: CMACParticipants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks
2 Wks Nicotine Patch+Nic Gum, No CMAC	Active comparator	Drug: Nicotine patch, Drug: Nicotine gumParticipants in this randomization arm received 2 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
2 Wks Nicotine Patch+Nic Gum plus CMAC	Active comparator	Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: CMACParticipants in this randomization arm received 2 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
6 Weeks of Nicotine Patch Only, No CMAC	Active comparator	Drug: Nicotine patchParticipants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks
6 Weeks of Nicotine Patch Only plus CMAC	Active comparator	Drug: Nicotine patch, Behavioral: CMACParticipants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks
6 Wks Nicotine Patch+Nic Gum, No CMAC	Active comparator	Drug: Nicotine patch, Drug: Nicotine gumParticipants in this randomization arm received 6 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
6 Wks Nicotine Patch+Nic Gum plus CMAC	Active comparator	Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: CMACParticipants in this randomization arm received 6 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Who may qualify

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

Key inclusion criteria (1 listed)

Callers will be eligible to participate in the study if they are English speaking; are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are interested in quitting and are willing to set a quit date; willing and able to use nicotine patch and nicotine gum; agree to receive four follow-up counseling calls from Free \& Clear (the quitline vendor for the State of Wisconsin); provide verbal informed consent; and provide contact information and agree to take four study follow-up calls from staff at the University of Wisconsin Center for Tobacco Research and Intervention.

Key exclusion criteria (1 listed)

Callers will be excluded if they are under the age of 18; are pregnant or breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are unwilling or unable to use study NRT medications; are currently using a cessation medication (NRT, bupropion, varenicline); or have medical exclusions as per FDA-approved product labeling.

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
Nicotine patchIf > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day	Drug	2 Weeks of Nicotine Patch Only plus CMAC, 2 Weeks of Nicotine Patch Only, No CMAC, 2 Wks Nicotine Patch+Nic Gum plus CMAC, 2 Wks Nicotine Patch+Nic Gum, No CMAC, 6 Weeks of Nicotine Patch Only plus CMAC, 6 Weeks of Nicotine Patch Only, No CMAC, 6 Wks Nicotine Patch+Nic Gum plus CMAC, 6 Wks Nicotine Patch+Nic Gum, No CMAC
Nicotine gumAlso: Nicotine polacrilexIf < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.	Drug	2 Wks Nicotine Patch+Nic Gum plus CMAC, 2 Wks Nicotine Patch+Nic Gum, No CMAC, 6 Wks Nicotine Patch+Nic Gum plus CMAC, 6 Wks Nicotine Patch+Nic Gum, No CMAC
CMACAlso: Cognitive Medication Adherence CounselingCMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.	Behavioural	2 Weeks of Nicotine Patch Only plus CMAC, 2 Wks Nicotine Patch+Nic Gum plus CMAC, 6 Weeks of Nicotine Patch Only plus CMAC, 6 Wks Nicotine Patch+Nic Gum plus CMAC

Primary outcome

7-Day Point Prevalence Abstinence From Smoking by Intervention
Time frame: 26 weeks after the target quit smoking date
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
Time frame: 26 weeks after the target quit smoking date
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.

1 secondary outcome

Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
Time frame: 26 weeks after the target quit smoking date

Results and safety

Results posted to the registry on 24 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2 Weeks of Nicotine Patch Only, No CMAC	119	90
2 Weeks of Nicotine Patch Only Plus CMAC	126	94
2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC	123	101
2 Weeks of Nicotine Patch+Nicotine Gum and CMAC	122	86
6 Weeks of Nicotine Patch Only, No CMAC	122	91
6 Weeks of Nicotine Patch Only Plus CMAC	127	99
6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC	121	98
6 Weeks of Nicotine Patch+Nicotine Gum and CMAC	127	98

Primary outcome: 7-Day Point Prevalence Abstinence From Smoking by Intervention

Time frame: 26 weeks after the target quit smoking date. Number. Unit: Percentage of participants not smoking

Measure	Two Weeks of Nicotine Replacement Therapy (NRT) n = 490	Six Weeks of Nicotine Replacement Therapy (NRT) n = 497	NRT Monotherapy (Nicotine Patch Only) n = 494	NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum) n = 493	Standard Cessation Counseling (No CMAC) n = 485	Standard Cessation Counseling Plus CMAC) n = 502
Value	43.3	48.9	42.3	49.9	47.6	44.6

Two Weeks of Nicotine Replacement Therapy (NRT) vs NRT Monotherapy (Nicotine Patch Only): Odds Ratio (OR): 1.26 (95% CI 0.98 to 1.61), p = .076, Regression, Logistic
NRT Monotherapy (Nicotine Patch Only) vs NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum): Odds Ratio (OR): 1.36 (95% CI 1.06 to 1.75), p = .017, Regression, Logistic
Standard Cessation Counseling (No CMAC) vs Standard Cessation Counseling Plus CMAC): Odds Ratio (OR): 0.89 (95% CI 0.69 to 1.14), p = .343, Regression, Logistic

Population analysed: The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.

Primary outcome: 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group

Time frame: 26 weeks after the target quit smoking date. Number. Unit: Percentage of participants not smoking

Measure	Two Weeks of Nicotine Patch Only n = 245	Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum) n = 245	Six Weeks of Nicotine Patch Only n = 249	Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum) n = 248
Value	38.4	48.2	46.2	51.6

Two Weeks of Nicotine Patch Only vs Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum): Odds Ratio (OR): 1.49 (95% CI 1.04 to 2.14), p = .029, Regression, Logistic
Two Weeks of Nicotine Patch Only vs Six Weeks of Nicotine Patch Only: Odds Ratio (OR): 1.38 (95% CI 0.96 to 1.97), p = .079, Regression, Logistic
Two Weeks of Nicotine Patch Only vs Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum): Odds Ratio (OR): 1.71 (95% CI 1.20 to 2.45), p = .003, Regression, Logistic

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Information about adverse events was collected during the 6-week post-quit period of study interventions. The quitline vendor for the study, Free & Clear (Seattle, WA), dispensed all study medications and addressed adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Two Weeks of Nicotine Patch Only	0 of 245 (0%)	0 of 245 (0%)	Not reported
Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)	0 of 245 (0%)	0 of 245 (0%)	Not reported
Six Weeks of Nicotine Patch Only	0 of 249 (0%)	0 of 249 (0%)	Not reported
Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)	0 of 248 (0%)	0 of 248 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22992296Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res. 2013 Mar;15(3):718-28. doi: 10.1093/ntr/nts186. Epub 2012 Sep 19.
University of Wisconsin Center for Tobacco Research and InterventionLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Upon request, clinical trial data will be shared with other investigators in the form of de-identified datasets. Requests can be sent to Stevens S. Smith, Ph.D., at sss@ctri.wisc.edu

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Cigarette Smoking, Smoking Cessation

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.

Stevens S Smith, PhD principal investigator

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

Paula A Keller, MPH study director

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicotine patch, Nicotine gum and CMAC in people with Smoking and Smoking Cessation, run by University of Wisconsin, Madison at 2 sites 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 1 inclusion and 1 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 24 Apr 2013). 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?

7-Day Point Prevalence Abstinence From Smoking by Intervention (time frame: 26 weeks after the target quit smoking date). The study lists 2 primary outcomes in all. 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 NCT01087905, which also lists 1 linked publication.

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 8 Dec 2016.