The Long-Term Quitting (Smoking Cessation) Study
- Conditions
- Smoking Cessation
- Interventions
- Behavioral: Preparation Phase Recycling CounselingBehavioral: Preparation Phase Control TreatmentBehavioral: Preparation Phase Behavioral Reduction CounselingBehavioral: Cessation Phase Supportive CounselingBehavioral: Cessation Phase Skill Training CounselingBehavioral: Cessation Phase Brief InformationDrug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
- Registration Number
- NCT02564315
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking. This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an innovative multi-phase approach - - to test post-relapse treatments designed to assist smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR) treatments that are applied at two stages following relapse: 1) RR Preparation Phase treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to quit smoking will make an initial quit attempt in the Quit Phase (cessation medication + counseling). Participants who relapse will be randomized to one of three RR Preparation Phase treatments (Behavioral \[Smoking\] Reduction Counseling + the Nicotine Mini-Lozenge; Recycling Counseling that encourages participants to quit again as soon as possible; and Preparation Phase Control). RR Preparation Phase participants (other than controls) who elect to try a new quit attempt will be randomized to one of four RR Cessation Phase treatments based on a 2X2 fully-crossed factorial design testing two factors: Supportive Counseling (vs. Brief Information) and Skill Training (vs. Brief Information). All RR Cessation Phase participants will receive 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine mini-lozenge). The investigators hypothesize that RR Preparation Phase Reduction treatment will significantly increase long-term abstinence rates relative to the Preparation Phase Control condition.
- Detailed Description
This study aims to identify effective Relapse Recovery (RR) treatments to assist smokers who relapse after an initial quit attempt. The study will use a sequential, multiple assignment, randomized trial (SMART) design with three phases. In a SMART design, randomization occurs at more than one stage, with randomization at a later stage based on response to treatment at an earlier stage. The three phases in this SMART study are as follows:
1. Phase 1 consists of the Quit Phase in which all participants (smokers motivated to quit smoking) will be offered evidence-based cessation treatment (cessation medication plus counseling). Participants who relapse will be eligible to proceed to the next phase which involves Relapse Recovery (RR) Preparation treatment.
2. Phase 2 consists of RR Preparation Phase treatments in which relapsed participants from the Quit Phase will be randomized to three arms: (a) Recycling Counseling (where participants are encouraged to quit again as soon as possible); (b) Behavioral Reduction Counseling + Nicotine Mini-Lozenge (which targets smoking reduction and preparation for a new quit attempt); and (c) Preparation Phase Control (continuation of Quit Phase treatment plus advice to seek additional help from the Wisconsin Tobacco Quit Line or their clinic care provider).
3. Phase 3 consists of RR Cessation Phase treatments in which non-control (i.e. Recycling or Behavioral Reduction) Preparation Phase participants who elect to make a new quit attempt will be randomized to one of four treatment conditions in a 2X2 fully-crossed factorial design: (a) Supportive Counseling + Skill Training; (b) Supportive Counseling + Brief Information; (c) Skill Training + Brief Information; and (d) Brief Information Only. All participants will receive 8 weeks of combination nicotine replacement therapy (Nicotine Patch + Nicotine Mini-Lozenge). Brief Information will consist of generic information about the importance of taking the medication and how to use it, information about side effects/safety and what to do in case of problems, and participants will also be given encouragement.
Smoking status will be assessed 14 months after randomization to RR Preparation Phase treatment. The investigators hypothesize that 7-day point point-prevalence abstinence rates will be 15% for the Preparation Phase Control condition, 25% for the Recycling condition, and 35% for the Behavioral Reduction condition. The investigators propose that any increase in abstinence of 15% or higher would be clinically significant. The investigators did not power the study to demonstrate a significant difference between the two active RR Preparation Phase treatments. Therefore, the investigators anticipate that only the RR Behavioral Reduction treatment will significantly increase long-term abstinence rates (primary outcome: Biochemically-confirmed 7-Day Point Prevalence Abstinence at 14 Months post-randomization to Phase 2 Preparation treatment) over those produced by the Preparation Phase Control condition. Because of limitations in statistical power, analyses of RR Cessation Phase treatments will be exploratory only (secondary outcome: Self-Reported 7-Day Point Prevalence Abstinence at 26 Weeks post-randomization to Phase 3 Cessation treatment).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1154
- 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),
- motivation to quit smoking, and
- planning to remain in the intervention catchment area for at least 2 years and 2 months, .
- Currently taking bupropion or varenicline,
- unwillingness to cease other forms of nicotine replacement or Chantix (also called 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 4 weeks, history of a serious skin or allergic reaction to using the Nicotine patch,
- 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 Reduction/Supportive+Skill Counseling Nicotine Mini-Lozenge for 11 Months This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive Counsel+Brief Info Nicotine Mini-Lozenge for 11 Months This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Skill Counseling+Brief Info Nicotine Mini-Lozenge for 11 Months This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Brief Info+Brief Info Nicotine Mini-Lozenge for 11 Months This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive+Skill Counseling Cessation Phase Supportive Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive+Skill Counseling Preparation Phase Behavioral Reduction Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive+Skill Counseling Cessation Phase Skill Training Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Skill Counseling+Brief Info Preparation Phase Behavioral Reduction Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive Counsel+Brief Info Preparation Phase Behavioral Reduction Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Skill Counseling+Brief Info Cessation Phase Brief Information This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive+Skill Counseling Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive Counsel+Brief Info Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive+Skill Counseling Preparation Phase Recycling Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive+Skill Counseling Cessation Phase Supportive Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Skill Counseling+Brief Info Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive+Skill Counseling Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive Counsel+Brief Info Cessation Phase Supportive Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Supportive Counsel+Brief Info Cessation Phase Brief Information This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Skill Counseling+Brief Info Cessation Phase Skill Training Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Brief Info+Brief Info Preparation Phase Behavioral Reduction Counseling This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive Counsel+Brief Info Preparation Phase Recycling Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Brief Info+Brief Info Cessation Phase Brief Information This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Reduction/Brief Info+Brief Info Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Reduction Treatment and Phase 3 (Cessation) Brief Information. More specifically, treatments include the following: Phase 2: Nicotine Mini-Lozenge for 11 Months; Preparation Phase Behavioral Reduction Counseling; Phase 3: Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Skill Counsel+Brief Info Cessation Phase Skill Training Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Skill Counsel+Brief Info Cessation Phase Brief Information This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive+Skill Counseling Cessation Phase Skill Training Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Skill Training Counseling. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Skill Training Counseling; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive Counsel+Brief Info Cessation Phase Supportive Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive Counsel+Brief Info Cessation Phase Brief Information This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Brief Info+Brief Info Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Supportive Counsel+Brief Info Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Supportive Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Supportive Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Skill Counsel+Brief Info Preparation Phase Recycling Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Brief Info+Brief Info Preparation Phase Recycling Counseling This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Brief Info+Brief Info Cessation Phase Brief Information This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Recycling/Skill Counsel+Brief Info Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge This arm includes Phase 2 (Preparation) Recycling Treatment and Phase 3 (Cessation) Skill Training Counseling and Brief Information. More specifically, treatments include the following: Phase 2: Preparation Phase Recycling Counseling; Phase 3: Cessation Phase Skill Training Counseling; Cessation Phase Brief Information; Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge Preparation Phase Control/No Phase 3 Preparation Phase Control Treatment This arm includes Phase 2 (Preparation) Control Treatment and No Phase 3 (Cessation) Treatment. More specifically, treatments include the following: Phase 2: Preparation Phase Control Treatment Phase 3: No Treatment
- Primary Outcome Measures
Name Time Method Biochemically-confirmed 7-Day Point Prevalence Abstinence 14 Months after randomization to Phase 2 Preparation treatment Participants who self-report no smoking for the past 7 days at the assessment endpoint (14 months post-randomization to Phase 2 Preparation treatment) and who provide an exhaled breath sample for carbon monoxide testing with a concentration no higher than 5 parts per million will be considered to meet criteria for Biochemically-confirmed 7-Day Point Prevalence Abstinence. Participants who do not meet these criteria will be considered to be relapsed (smoking).
- Secondary Outcome Measures
Name Time Method Self-Reported 7-Day Point Prevalence Abstinence 26 Weeks after randomization to the Phase 3 Cessation treatment Participants who self-report no smoking for the past 7 days at the assessment endpoint (26 weeks post-randomization to Phase 3 Cessation treatment) will be considered to meet criteria for Self-Reported 7-Day Point Prevalence Abstinence. Participants who report any smoking in the past 7 days at the assessment endpoint will be considered to be relapsed (smoking).
Trial Locations
- Locations (1)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States