The Avenues Study: Dual Use Cessation
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
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
Treatments tested in this trial
- Varenicline
- Nicotine patch
- Dual Focused Cessation Counseling
- Smoking Focused Cessation Counseling
- Counseling Intensity: 1 Session
- Counseling Intensity: 4 Sessions
Treatment groups
500 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov