Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder (NCT06582888) | Clinical Trial Compass
RecruitingEarly Phase 1
Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
United States200 participantsStarted 2024-11-19
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Persons, aged 22+
. Ability to take oral medication and be willing to adhere to the dosing regimen
. For participants able to become pregnant: use of highly effective contraception during study enrollment
. Current daily tobacco use (use on 7 days per week, on average, ≥5 cigarettes per day, in the previous 3 months)
. Tobacco use history ≥3 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in early Phase 1 and seems focused on testing a virtual reality tool as a way to measure cravings — does that mean it's more about developing a measurement method than actually treating my nicotine addiction, and if so, what direct benefit might I personally see from joining?
2Since this study is measuring 'attentional bias' using virtual reality before and after some kind of treatment, can you explain what that treatment actually involves and whether there are any known risks with VR-based sessions for someone in my situation?
3Given that this is an early-phase study still in the process of validating a biomarker, would it make more sense for me to pursue an established cessation treatment first — like nicotine replacement therapy or varenicline — rather than participating in this trial right now?
4The trial is tracking how often I use nicotine and how strong my cravings are, which means I'd likely need to self-report or be monitored regularly — how much time and how many visits would this realistically require, and is that something my schedule could actually support?
5Because this is an early Phase 1 study, what is currently known about whether the VR attentional bias approach it's testing has shown any promising signals in reducing cravings or nicotine use in earlier research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment
Timeframe: during each in-person session, at baseline and on average 8 days post baseline assessment
2
Nicotine craving
Timeframe: during each in-person session, at baseline and on average 8 days post baseline assessment
3
Nicotine craving
Timeframe: through study completion, an average of 30 days
4
Nicotine use episodes
Timeframe: during each in-person session, at baseline and on average 8 days post baseline assessment
5
Nicotine use episodes
Timeframe: through study completion, an average of 30 days
. Contraindications/conditions with special precautions for varenicline treatment (i.e., history of serious hypersensitivity or skin reactions to varenicline, history of severe renal impairment, seizures, severe cardiovascular disease, chronic or severe nausea, Stevens-Johnson syndrome, erythema multiforme, pregnancy or nursing)
. Medical or psychiatric history affecting brain development (i.e., history and/or treatment of neurologic disorders, severe head trauma with loss of consciousness \>2 minutes, or current severe Diagnostic and Statistical Manual 5th edition (DSM-5) psychiatric disorders other than tobacco use disorders)
. Current suicidal ideation or history of suicide attempt or self-mutilatory acts in the past 12 months
. Other recreational drug use in the past 30 days (besides alcohol and cannabis) verified by oral and urine fluid toxicology
. Visual/vestibular problems that may make task completion difficult (i.e., motion sickness, difficulty balancing, blindness)
. Treatment seeking for tobacco use disorder/intent to quit within 30 days