Clinical trial NCT06474299: The Avenues Study: Dual Use Cessation
Official title: Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Smoking Cessation
Electronic Cigarette Use
Keywords: ENDS
Cessation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-06-25
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2x2 factorial screening trial
Primary purpose: TREATMENT

Brief summary: The overarching goal of this research is to determine the most effective approach for helping dual users of cigarettes and electronic nicotine delivery systems (ENDS) quit smoking. 500 participants will be enrolled and can expect to be on study for 12 months.

Detailed description: To be efficient and maximize translation potential, the investigators will use the efficient Multiphase Optimization Strategy (MOST) to identify an optimal intervention to help people who use both cigarettes and ENDS quit smoking cigarettes. As such, in this randomized 2x2x2 factorial screening trial, the investigators will examine three intervention factors:

1. Pharmacotherapy (varenicline vs. nicotine patch)
2. Counseling Intensity (4 vs. 1 session)
3. Counseling Approach (Dual Focused vs. Smoking Focused).

The Dual Focused counseling approach will encourage participants to quit their ENDS use as part of their smoking cessation attempt. The Smoking Focused counseling approach will encourage participants to quit smoking but not vaping and to use their ENDS strategically to deal with urges in service of harm reduction. There is theoretical and empirical support for these pharmacologic and counseling approaches and intensities.

Participants (N=500) will be dual users of cigarettes (\>4 cigs/day for the last 6 months) and ENDS (vape weekly for at least 6 months) who are motivated to quit smoking and willing try to quit vaping, if asked to do so. Participants will be randomized to receive either varenicline or nicotine patches for 12 weeks, to receive either one or four 15-20-minute counseling sessions, and to receive counseling that is either dual focused or smoking focused. Dual Focused Cessation will focus on quitting both smoking and vaping on the target quit date (TQD). Pre-TQD, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places or at specific times of day). Post-TQD, participants will focus on building smoking and vaping cessation skills (e.g., coping with cravings to smoke or vape, avoiding smoking and vaping cues). Smoking Focused Cessation will focus on quitting smoking on the TQD and using ENDS as a behavioral substitute (i.e., using ENDS as a cigarette substitute). Pre-TQD, participants will be instructed to change smoking patterns (e.g., vaping rather than smoking in specific places or at specific times of day, vaping first in the morning rather than smoking) and practice smoking cessation coping strategies (e.g., substituting ENDS for cigarettes, avoiding smoking cues). Participants will be advised to quit smoking on the TQD and not worry about quitting vaping at this point. Participants will complete daily measures of smoking, vaping, and potential change mechanisms (e.g., craving, smoking reward, self-efficacy) via ecological momentary assessment (EMA) for 2 weeks pre-TQD and 2 weeks post-TQD. Follow-up will occur for 12 months post-TQD.

Primary Objective: Determine which pharmacologic and counseling approaches are especially effective, alone or in combination, in helping dual users quit smoking.

Secondary Objectives:

* Examine the effects of the treatments on variables that may mediate treatment effects on smoking cessation.
* Examine

  1. changes in vaping intensity and vaping cessation
  2. moderators of treatment effects (e.g., cigarette dependence, race, menthol use, ENDS characteristics), and
  3. whether continued vaping is related to cigarette lapse and relapse amongst those who have quit smoking.

Eligibility criteria: Inclusion Criteria:

* Able to read and communicate in English
* Willing to set a quit date to quit smoking cigarettes in the next 30 days
* Willing and medically able to use varenicline and nicotine patches
* Smoking ≥ 5 cigarettes per day for the past 6 months
* Vaping weekly for at least 6 months
* Willing to stop using nicotine replacement or varenicline
* Willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation

Exclusion Criteria:

* Plans to move out of the area for the next 12 months
* Currently in treatment for psychosis or bipolar disorder
* If they are currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
* Currently pregnant or breastfeeding. If a participant becomes pregnant while in the study, they will be allowed to continue in the study but will no longer receive study medications. They will also be asked to return any unused study medications.

Primary outcomes:
measure: 52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
timeFrame: up to 52 weeks
Secondary outcomes:
measure: 26-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
timeFrame: up to 26 weeks
measure: 7-day point-prevalence abstinence from smoking and vaping at Weeks 26 and 52 post-TQD
timeFrame: up to 52 weeks
Other outcomes:
measure: Number of Participants Achieving Initial Smoking Abstinence
timeFrame: up to 2 weeks
measure: 12-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
timeFrame: up to 12 Weeks (end of treatment)
measure: 7-day point-prevalence abstinence from smoking and vaping at Week 12
timeFrame: up to 12 Weeks (end of treatment)
measure: Number of Participants Achieving Initial Abstinence from Smoking and Vaping
timeFrame: up to 2 weeks
measure: Number of days until first cigarette following initial cessation
timeFrame: up to 52 weeks post-TQD
measure: Number of days until 7 consecutive days of smoking following initial cessation
timeFrame: up to 52 weeks post-TQD
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Megan E Piper, PhD
role: PRINCIPAL_INVESTIGATOR
References: