The Long-Term Quitting (Smoking Cessation) Study
The Long-Term Quitting Study: Testing Relapse Recovery Intervention Components
3 other identifiers
interventional
1,154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedStudy Start
First participant enrolled
October 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2019
CompletedFebruary 17, 2020
February 1, 2020
4 years
September 29, 2015
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemically-confirmed 7-Day Point Prevalence Abstinence
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).
14 Months after randomization to Phase 2 Preparation treatment
Secondary Outcomes (1)
Self-Reported 7-Day Point Prevalence Abstinence
26 Weeks after randomization to the Phase 3 Cessation treatment
Study Arms (9)
Reduction/Supportive+Skill Counseling
ACTIVE COMPARATORThis 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
ACTIVE COMPARATORThis 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
ACTIVE COMPARATORThis 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
ACTIVE COMPARATORThis 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+Skill Counseling
ACTIVE COMPARATORThis 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
ACTIVE COMPARATORThis 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
ACTIVE COMPARATORThis 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
ACTIVE COMPARATORThis 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
Preparation Phase Control/No Phase 3
PLACEBO COMPARATORThis 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
Interventions
Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.
Participants randomized to receive this treatment receive manual-based counseling calls and visits over the course of 11 months. The ultimate goal will be smoking that is reduced in amount and location. Case managers and participants will collaboratively identify a set of steps to progressively reduce smoking. The primary vehicles for change are to encourage substitution of the nicotine mini-lozenge for cigarettes and to reduce the contexts in which smoking occurs. Counseling will counter post-lapse demoralization by emphasizing participants' progress, the value of smoking reduction as a transitional goal, and the critical value of ongoing treatment engagement. Evidence of progress in reduction of smoking, and smoking contexts will be used to build self-efficacy.
Participants randomized to receive this treatment condition will be encouraged to commit to a new quit date as soon as they feel ready. In the counseling sessions, participants will be encouraged to discuss reasons for and concerns about quitting as well as barriers to setting a quit date.
Participants randomly assigned to the Preparation Phase Control Treatment condition will continue to receive the Initial Cessation usual care treatment (8 weeks of nicotine patch; two coaching sessions), but will also be told that they can receive additional treatment at no cost from the Wisconsin Tobacco Quitline (WTQL).
Supportive Counseling will be consistent with the Public Health Service (PHS) Clinical Practice Guideline (Fiore et al., 2008) and will involve encouragement, a focus on short-term goals, discussion of participant values (what the participant feels would be good and healthy for them in the long run) and how these values are congruent with cessation, emphasis on the patient and the counselor being a team, encouragement for the participant to generate a quitting strategy with the message that smokers often have a good sense of what will work for them, and prompts for the participant to explore his/her feelings about quitting and feelings of optimism and concern (i.e., to use the counselor as a sounding board).
Skill training Counseling will: 1) carefully assess smoking cue contexts and opportunities to smoke, to identify problems encountered in the prior quit attempt; 2) develop specific plans for avoiding such contexts and identify skills for coping with them; 3) develop plans for negotiating with others who smoke; 4) develop lifestyle changes to reduce future smoking opportunities and contexts; and 5) assign homework and assess execution of assigned skills. Participants will receive coping menus that provide personalized coping/avoidance options and "coping reports" that assess coping execution over time and troublesome contexts and cues around which counseling will be focused. There will be praise for any progress and a collaborative determination of barriers to skill execution.
Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.
All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).
Eligibility Criteria
You may qualify if:
- 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, .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Penn State Universitycollaborator
- University of Illinois at Chicagocollaborator
Study Sites (1)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711-2027, United States
Related Publications (1)
Schlam TR, Baker TB, Piper ME, Cook JW, Smith SS, Zwaga D, Jorenby DE, Almirall D, Bolt DM, Collins LM, Mermelstein R, Fiore MC. What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments. Addiction. 2024 May;119(5):898-914. doi: 10.1111/add.16428. Epub 2024 Jan 28.
PMID: 38282258DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tanya Schlam, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
September 30, 2015
Study Start
October 30, 2015
Primary Completion
November 5, 2019
Study Completion
November 5, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After publication of the main findings.
- Access Criteria
- Approval of a data request by the investigators.
We will make the final de-identifed datasets available in standard file formats by request from other researchers in a timely manner (no later than the acceptance for publication of the main findings from the final dataset).