Trials / Recruiting
RecruitingNCT06582888
Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Varenicline Tartrate | varenicline (target dose 1mg twice daily) |
| DRUG | Placebo | matched placebo |
Timeline
- Start date
- 2024-11-19
- Primary completion
- 2028-08-15
- Completion
- 2028-08-15
- First posted
- 2024-09-03
- Last updated
- 2026-03-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06582888. Inclusion in this directory is not an endorsement.