Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06582888
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Craving
  • Nicotine Addiction

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Varenicline Tartrate — DRUG
    varenicline (target dose 1mg twice daily)
  • Placebo — DRUG
    matched placebo

Study Details

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.

Key Dates

Start date
Nov 19, 2024
Status verified
Mar 2026
Primary completion
Aug 15, 2028
Completion
Aug 15, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Varenicline
    Following the baseline assessment, participants randomized to receive varenicline will complete an 8-day titration period to achieve the target dose. Titration of varenicline will be as follows: 0.5 mg once daily for Days 1-3, 0.5 mg twice daily for Days 4-7, and 1 mg twice daily on Day 8. Participants then return to the lab on Day 9 (or Days 10, 11 if necessary) for testing at the target dosage (1 mg twice daily) and continue at that dose for eight additional days (Days 10-17) for mobile monitoring.
  • Placebo Comparator: Placebo
    Following the baseline assessment, participants randomized to receive placebo pill will follow the same dosing schedule as the active arm. They will return to the lab on Day 9 (or Days 10, 11 if necessary) for testing and continue at that dosing schedule for eight additional days (Days 10-17) for mobile monitoring.

Primary Outcome Measure

Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment [ Time Frame: during each in-person session, at baseline and on average 8 days post baseline assessment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University California, San DiegoSan DiegoCalifornia92093
Research Coordinator
[email protected]
858-480-1251
Kelly Courtney, Ph.D. (PRINCIPAL_INVESTIGATOR)

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University California, San Diego· San Diego, CA

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