Clinical trial NCT02564315: The Long-Term Quitting (Smoking Cessation) Study
Official title: The Long-Term Quitting Study: Testing Relapse Recovery Intervention Components
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Smoking
Cessation
Tobacco
Relapse
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Penn State University
name: University of Illinois at Chicago
First posted: 2015-09-30
Enrollment: 1154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. age \>=18 years,
2. smoking \>4 cigarettes/day for the previous 6 months,
3. able to read, write, and speak English,
4. have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts, and
5. 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),
6. motivation to quit smoking, and
7. planning to remain in the intervention catchment area for at least 2 years and 2 months, .

Exclusion Criteria:

1. Currently taking bupropion or varenicline,
2. unwillingness to cease other forms of nicotine replacement or Chantix (also called Varenicline),
3. 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,
4. diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years and,
5. 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.

Primary outcomes:
measure: Biochemically-confirmed 7-Day Point Prevalence Abstinence
timeFrame: 14 Months after randomization to Phase 2 Preparation treatment
Secondary outcomes:
measure: Self-Reported 7-Day Point Prevalence Abstinence
timeFrame: 26 Weeks after randomization to the Phase 3 Cessation treatment
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Tanya Schlam, PhD
role: STUDY_DIRECTOR
References: