A Comparative Effectiveness RCT of Optimized Cessation Treatments

Phase 4

Completed

Conditions: Smoking Cessation

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

Registration Number: NCT02301403

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 623

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abstinence-Optimized Cessation Treatment	Intensive In-Person Cessation Counseling	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.
Modern Usual Care	Nicotine patch	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).
Modern Usual Care	in-person counseling and quitline counseling	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).
Abstinence-Optimized Cessation Treatment	Extended Maintenance Counseling Calls	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.
Abstinence-Optimized Cessation Treatment	Preparation Nicotine Mini-Lozenges	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.
Abstinence-Optimized Cessation Treatment	Combination NRT (nicotine patch + nicotine mini-lozenges)	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.
Abstinence-Optimized Cessation Treatment	Automated Adherence Calls	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Abstinence From Smoking	6 months post treatment	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).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
🇺🇸
Madison, Wisconsin, United States