Actively Recruiting
Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
Led by University of California, San Diego · Updated on 2026-03-16
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating varenicline as a treatment for tobacco use disorder and nicotine craving in adults aged 22 and older who are daily tobacco cigarette users. This early phase 1 clinical trial aims to advance understanding of VR-based attentional bias as a biomarker for tobacco use disorder by comparing varenicline to placebo in a randomized, quadruple-blind study. Participants will be randomly assigned to receive either varenicline or a matched placebo. Those in the varenicline group will undergo an 8-day dose escalation starting at 0.5 mg once daily, increasing to a target dose of 1 mg twice daily by Day 8. Both groups will have assessments using a virtual reality nicotine cue exposure task at baseline and after reaching the target dose. Following in-person testing on Day 9 (or up to Day 11 if needed), participants continue their assigned dosing for eight more days while being monitored remotely via mobile assessments. During the study, participants will complete virtual reality tests measuring attentional bias to nicotine cues and report nicotine craving and use episodes at baseline and after treatment. Mobile assessments will track nicotine use behaviors for eight days at the target dose and by phone 30 days later. The primary outcomes include changes in VR attentional bias, nicotine craving, and nicotine use episodes over the study period. Participants are expected to be available for the full duration of the trial to complete all procedures and follow-up assessments.
CONDITIONS
Brief Title
Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Age 22 years or older
- Ability and willingness to take oral medication as prescribed
- For women able to become pregnant, use of highly effective contraception during the study
- Current daily tobacco use (at least 5 cigarettes per day on average, 7 days per week) in the last 3 months
- Tobacco use history of at least 3 years
- Report of nicotine craving in the past week
You will not qualify if you...
- Contraindications or special precautions for varenicline (e.g., serious hypersensitivity, severe renal impairment, seizures, severe cardiovascular disease, chronic or severe nausea, pregnancy or nursing)
- Medical or psychiatric history affecting brain development or current severe psychiatric disorders other than tobacco use disorder
- Current suicidal thoughts or suicide attempt/self-harm in the past 12 months
- Recreational drug use in the past 30 days excluding alcohol and cannabis
- Visual or balance problems that may interfere with task completion (e.g., motion sickness, blindness)
- Currently seeking treatment for tobacco use disorder or intending to quit within 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 days
Participants receive either varenicline or placebo following a titration schedule to reach the target dose, followed by continued dosing while undergoing mobile monitoring.
1 baseline visit and 1 follow-up visit around Day 9, plus mobile monitoring Days 10-17
Trial Site Locations
Total: 1 location
1
University California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
R
Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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