The Avenues Study: Dual Use Cessation
Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape
University of Wisconsin, Madison
500 participants
Sep 24, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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
- Saliva cotinine >20 ng/ml
- US resident
- Own a Smartphone to use and download an app to record data
Exclusion Criteria3
- 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.
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Interventions
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
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 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 will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).
Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).
Participants assigned to intensive counseling will have four, 15-20-minute sessions.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06474299