Smoking CessationPhase 4NCT02564315
The Long-Term Quitting (Smoking Cessation) Study
A Phase 4 study testing Nicotine Mini-Lozenge for 11 Months, Preparation Phase Behavioral Reduction Counseling and Preparation Phase Recycling Counseling in people with Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine Mini-Lozenge for 11 Months, Preparation Phase Behavioral Reduction Counseling and Preparation Phase Recycling Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,154 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2015to 5 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711-2027
About this study
Official title: The Long-Term Quitting Study: Testing Relapse Recovery Intervention Components
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.
Read the 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:
- 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.
- 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).
- 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).
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Mini-Lozenge for 11 Months, Preparation Phase Behavioral Reduction Counseling, Preparation Phase Recycling Counseling, Preparation Phase Control Treatment, Cessation Phase Supportive Counseling
- Keywords
- Smoking, Cessation, Tobacco, Relapse
- Medical subject headings
- Smoking Cessation, Smoking, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Mini-Lozenge for 11 MonthsDrug
Also called Nicotine Mini-Lozenge
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.
Preparation Phase Behavioral Reduction CounselingBehavioural
Also called Phase 2 Reduction Counseling
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.
Preparation Phase Recycling CounselingBehavioural
Also called Phase 2 Recycling Counseling
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.
Preparation Phase Control TreatmentBehavioural
Also called Phase 2 Control Treatment
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).
Cessation Phase Supportive CounselingBehavioural
Also called Phase 3 Supportive Counseling
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).
Cessation Phase Skill Training CounselingBehavioural
Also called Phase 3 Skill Training Counseling
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.
Cessation Phase Brief InformationBehavioural
Also called Phase 3 Brief Information
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.
Cessation Phase Nicotine Patch + Nicotine Mini-LozengeDrug
Also called Cessation Phase Combination NRT
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).
| Study group | Role | What they receive |
|---|---|---|
| Reduction/Supportive+Skill Counseling | Active comparator | 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 Receives: Drug: Nicotine Mini-Lozenge for 11 Months; Behavioral: Preparation Phase Behavioral Reduction Counseling; Behavioral: Cessation Phase Supportive Counseling; Behavioral: Cessation Phase Skill Training Counseling; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Reduction/Supportive Counsel+Brief Info | Active comparator | 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 Receives: Drug: Nicotine Mini-Lozenge for 11 Months; Behavioral: Preparation Phase Behavioral Reduction Counseling; Behavioral: Cessation Phase Supportive Counseling; Behavioral: Cessation Phase Brief Information; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Reduction/Skill Counseling+Brief Info | Active comparator | 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 Receives: Drug: Nicotine Mini-Lozenge for 11 Months; Behavioral: Preparation Phase Behavioral Reduction Counseling; Behavioral: Cessation Phase Skill Training Counseling; Behavioral: Cessation Phase Brief Information; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Reduction/Brief Info+Brief Info | Active comparator | 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 Receives: Drug: Nicotine Mini-Lozenge for 11 Months; Behavioral: Preparation Phase Behavioral Reduction Counseling; Behavioral: Cessation Phase Brief Information; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Recycling/Supportive+Skill Counseling | Active comparator | 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 Receives: Behavioral: Preparation Phase Recycling Counseling; Behavioral: Cessation Phase Supportive Counseling; Behavioral: Cessation Phase Skill Training Counseling; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Recycling/Supportive Counsel+Brief Info | Active comparator | 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 Receives: Behavioral: Preparation Phase Recycling Counseling; Behavioral: Cessation Phase Supportive Counseling; Behavioral: Cessation Phase Brief Information; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Recycling/Skill Counsel+Brief Info | Active comparator | 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 Receives: Behavioral: Preparation Phase Recycling Counseling; Behavioral: Cessation Phase Skill Training Counseling; Behavioral: Cessation Phase Brief Information; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Recycling/Brief Info+Brief Info | Active comparator | 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 Receives: Behavioral: Preparation Phase Recycling Counseling; Behavioral: Cessation Phase Brief Information; Drug: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge |
| Preparation Phase Control/No Phase 3 | Placebo comparator | 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 Receives: Behavioral: Preparation Phase Control Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 Months after randomization to Phase 2 Preparation treatment
Secondary outcomes (1)
Self-Reported 7-Day Point Prevalence Abstinence
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).
Measured: 26 Weeks after randomization to the Phase 3 Cessation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start30 Oct 2015
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, University of Illinois at Chicago
- Responsible party
- Sponsor
- Investigators
- Tanya Schlam, PhD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564315
- Sponsor's protocol ID
- 2014-1041 LongTermQuitting
- Other IDs
- A534253, SMPH/MEDICINE/GEN INT MD
- Status last verified
- Feb 2020
- First submitted
- 29 Sep 2015
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 38282258
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-Term Quitting Study: Testing Relapse Recovery Intervention Components
- ClinicalTrials.gov ID
- NCT02564315
- Acronym / sponsor ID
- 2014-1041 LongTermQuitting
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Cessation, Tobacco, Relapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,154 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Penn State University, University of Illinois at Chicago
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Reduction/Supportive+Skill Counseling | Active comparator | Drug: Nicotine Mini-Lozenge for 11 Months, Behavioral: Preparation Phase Behavioral Reduction Counseling, Behavioral: Cessation Phase Supportive Counseling, Behavioral: Cessation Phase Skill Training Counseling, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Drug: Nicotine Mini-Lozenge for 11 Months, Behavioral: Preparation Phase Behavioral Reduction Counseling, Behavioral: Cessation Phase Supportive Counseling, Behavioral: Cessation Phase Brief Information, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Drug: Nicotine Mini-Lozenge for 11 Months, Behavioral: Preparation Phase Behavioral Reduction Counseling, Behavioral: Cessation Phase Skill Training Counseling, Behavioral: Cessation Phase Brief Information, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Drug: Nicotine Mini-Lozenge for 11 Months, Behavioral: Preparation Phase Behavioral Reduction Counseling, Behavioral: Cessation Phase Brief Information, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Behavioral: Preparation Phase Recycling Counseling, Behavioral: Cessation Phase Supportive Counseling, Behavioral: Cessation Phase Skill Training Counseling, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Behavioral: Preparation Phase Recycling Counseling, Behavioral: Cessation Phase Supportive Counseling, Behavioral: Cessation Phase Brief Information, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Behavioral: Preparation Phase Recycling Counseling, Behavioral: Cessation Phase Skill Training Counseling, Behavioral: Cessation Phase Brief Information, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Behavioral: Preparation Phase Recycling Counseling, Behavioral: Cessation Phase Brief Information, Drug: Cessation Phase Nicotine Patch + Nicotine Mini-LozengeThis 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 comparator | Behavioral: Preparation Phase Control TreatmentThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Mini-Lozenge for 11 MonthsAlso: Nicotine Mini-LozengeParticipants 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. | Drug | Reduction/Brief Info+Brief Info, Reduction/Skill Counseling+Brief Info, Reduction/Supportive Counsel+Brief Info, Reduction/Supportive+Skill Counseling |
| Preparation Phase Behavioral Reduction CounselingAlso: Phase 2 Reduction CounselingParticipants 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. | Behavioural | Reduction/Brief Info+Brief Info, Reduction/Skill Counseling+Brief Info, Reduction/Supportive Counsel+Brief Info, Reduction/Supportive+Skill Counseling |
| Preparation Phase Recycling CounselingAlso: Phase 2 Recycling CounselingParticipants 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. | Behavioural | Recycling/Brief Info+Brief Info, Recycling/Skill Counsel+Brief Info, Recycling/Supportive Counsel+Brief Info, Recycling/Supportive+Skill Counseling |
| Preparation Phase Control TreatmentAlso: Phase 2 Control TreatmentParticipants 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). | Behavioural | Preparation Phase Control/No Phase 3 |
| Cessation Phase Supportive CounselingAlso: Phase 3 Supportive CounselingSupportive 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). | Behavioural | Recycling/Supportive Counsel+Brief Info, Recycling/Supportive+Skill Counseling, Reduction/Supportive Counsel+Brief Info, Reduction/Supportive+Skill Counseling |
| Cessation Phase Skill Training CounselingAlso: Phase 3 Skill Training CounselingSkill 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. | Behavioural | Recycling/Skill Counsel+Brief Info, Recycling/Supportive+Skill Counseling, Reduction/Skill Counseling+Brief Info, Reduction/Supportive+Skill Counseling |
| Cessation Phase Brief InformationAlso: Phase 3 Brief InformationParticipants 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. | Behavioural | Recycling/Brief Info+Brief Info, Recycling/Skill Counsel+Brief Info, Recycling/Supportive Counsel+Brief Info, Reduction/Brief Info+Brief Info, Reduction/Skill Counseling+Brief Info, Reduction/Supportive Counsel+Brief Info |
| Cessation Phase Nicotine Patch + Nicotine Mini-LozengeAlso: Cessation Phase Combination NRTAll 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). | Drug | Recycling/Brief Info+Brief Info, Recycling/Skill Counsel+Brief Info, Recycling/Supportive Counsel+Brief Info, Recycling/Supportive+Skill Counseling, Reduction/Brief Info+Brief Info, Reduction/Skill Counseling+Brief Info, Reduction/Supportive Counsel+Brief Info, Reduction/Supportive+Skill Counseling |
Primary outcome
Biochemically-confirmed 7-Day Point Prevalence Abstinence
Time frame: 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).
1 secondary outcome
Self-Reported 7-Day Point Prevalence Abstinence
Time frame: 26 Weeks after randomization to the Phase 3 Cessation treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 38282258Schlam 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.
- University of Wisconsin Center for Tobacco Research and InterventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Schlam, PhD study director
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Mini-Lozenge for 11 Months, Preparation Phase Behavioral Reduction Counseling and Preparation Phase Recycling Counseling in people with Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically-confirmed 7-Day Point Prevalence Abstinence (time frame: 14 Months after randomization to Phase 2 Preparation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.