A Comparative Effectiveness RCT of Optimized Cessation Treatments

Study Overview
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Brief Summary
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This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.

Detailed Description
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The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package

Official Title
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A Comparative Effectiveness RCT of Optimized Cessation Treatments

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine patch
* Behavioral: in-person counseling and quitline counseling
* Drug: Preparation Nicotine Mini-Lozenges
* Drug: Combination NRT (nicotine patch + nicotine mini-lozenges)
* Behavioral: Intensive In-Person Cessation Counseling
* Behavioral: Extended Maintenance Counseling Calls
* Behavioral: Automated Adherence Calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >=18 years smoking >4 cigarettes/day for the previous 6 months able to read, write, and speak English have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts and if currently using NRT, agreeing to use only study medication for the duration of the study we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses) not currently attempting to quit smoking not intending to quit smoking (defined as no plans to quit in the next month) and planning to remain in the intervention catchment area for at least 12 months. Exclusion Criteria: currently taking bupropion or varenicline medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modern Usual Care<br>Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services). | Drug: Nicotine patch<br>* 8 weeks of nicotine patch<br>Behavioral: in-person counseling and quitline counseling<br>* a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website<br>|
| Experimental: Abstinence-Optimized Cessation Treatment<br>There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls. | Drug: Preparation Nicotine Mini-Lozenges<br>* Nicotine lozenge prior to attempting to quit smoking<br>Drug: Combination NRT (nicotine patch + nicotine mini-lozenges)<br>* 26 weeks of combination NRT as part of a quit smoking attempt<br>Behavioral: Intensive In-Person Cessation Counseling<br>* three 20-min In-person Cessation Counseling sessions<br>Behavioral: Extended Maintenance Counseling Calls<br>* 8 Maintenance-phase smoking cessation counseling sessions<br>Behavioral: Automated Adherence Calls<br>* 11 brief, automated calls reminding them to use their medications properly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abstinence From Smoking | The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide < 6 parts per million). | 6 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, cessation, tobacco