The Avenues Study: Dual Use Cessation

ConditionsSmoking Cessation Electronic Cigarette Use

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age21+

SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

Varenicline
Drug
0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily
Nicotine patch
Drug
Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.
Dual Focused Cessation Counseling
Behavioral
Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).
Smoking Focused Cessation Counseling
Behavioral
Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).
Counseling Intensity: 1 Session
Other intervention
Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).
Counseling Intensity: 4 Sessions
Other intervention
Participants assigned to intensive counseling will have four, 15-20-minute sessions.

Treatment groups

500 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Group A: Varenicline, Dual Focused, 1 sessionActive comparator 3 interventions

Group B: Varenicline, Dual Focused, 4 sessionsActive comparator 3 interventions

Group C: Varenicline, Smoking Focused, 1 sessionActive comparator 3 interventions

Group D: Varenicline, Smoking Focused, 4 sessionsActive comparator 3 interventions

Group E: Nicotine Patches, Dual Focused, 1 sessionActive comparator 3 interventions

Group F: Nicotine Patches, Dual Focused, 4 sessionsActive comparator 3 interventions

Group G: Nicotine Patches, Smoking Focused, 1 sessionActive comparator 3 interventions

Group H: Nicotine Patches, Smoking Focused, 4 sessionsActive comparator 3 interventions

Trial outcomes

Primary outcomes

52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes

52-week biochemically confirmed (anabasine\<2 ng/ml) 7-day point-prevalence abstinence from cigarettes

Time frame

up to 52 weeks

Secondary outcomes

26-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes

26-week biochemically confirmed (anabasine\<2 ng/ml) 7-day point-prevalence abstinence from cigarettes

Time frame

up to 26 weeks

7-day point-prevalence abstinence from smoking and vaping at Weeks 26 and 52 post-TQD

Biochemically confirmed with saliva cotinine \<30 ng/mL

Time frame

up to 52 weeks

Other outcomes

Number of Participants Achieving Initial Smoking Abstinence

Measured by self-reported 24-hours of cigarette abstinence within the first 2 weeks of the target quit day

Time frame

up to 2 weeks

12-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes

12-week biochemically confirmed (anabasine\<2 ng/ml) 7-day point-prevalence abstinence from cigarettes

Time frame

up to 12 Weeks (end of treatment)

7-day point-prevalence abstinence from smoking and vaping at Week 12

Biochemically confirmed with saliva cotinine \<30 ng/mL

Time frame

up to 12 Weeks (end of treatment)

Number of Participants Achieving Initial Abstinence from Smoking and Vaping

Measured by self-reported 24-hours of cigarette and ENDS abstinence within the first 2 weeks of the target quit day

Time frame

up to 2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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