The Avenues Study: Dual Use Cessation (NCT06474299) | Clinical Trial Compass
RecruitingPhase 4
The Avenues Study: Dual Use Cessation
United States500 participantsStarted 2024-09-24
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Saliva cotinine \>20 ng/ml
* US resident
* Own a Smartphone to use and download an app to record data
* have a working email so that they can receive links for video visits
Exclusion Criteria:
* 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.
What they're measuring
1
52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes