Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
University of California, San Diego
Summary
The proposed project will include enrollment of 200 daily tobacco cigarette users, ages 22+, from the San Diego community. Participants will be assessed on the VR Nicotine Cue Exposure paradigm then randomized (stratified on age and sex) to receive varenicline (target dose 1mg twice daily) or placebo (n per group=100; total N=200). Following eight days of titration, participants will be assessed again on the VR Nicotine Cue Exposure paradigm. They will then be followed via mobile assessments for eight days on target dose of varenicline, and 30-days post assessment by phone, to assess short-term nicotine use behaviors.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Persons, aged 22+ 4. Ability to take oral medication and be willing to adhere to the dosing regimen 5. For participants able to become pregnant: use of highly effective contraception during study enrollment 6. Current daily tobacco use (use on 7 days per week, on average, ≥5 cigarettes per day, in the pre…
Interventions
- DrugVarenicline Tartrate
varenicline (target dose 1mg twice daily)
- DrugPlacebo
matched placebo
Location
- University California, San DiegoSan Diego, California