NCT06582888 Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
| NCT ID | NCT06582888 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, San Diego |
| Condition | Nicotine Addiction |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2028-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2024-11-19 with a primary completion date of 2028-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 previous 3 months) 7. Tobacco use history ≥3 years 8. Endorsement of past week nicotine craving Exclusion Criteria: 1. 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) 2. 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) 3. Current suicidal ideation or history of suicide attempt or self-mutilatory acts in the past 12 months 4. Other recreational drug use in the past 30 days (besides alcohol and cannabis) verified by oral and urine fluid toxicology 5. Visual/vestibular problems that may make task completion difficult (i.e., motion sickness, difficulty balancing, blindness) 6. Treatment seeking for tobacco use disorder/intent to quit within 30 days
Contact & Investigator
Kelly Courtney, Ph.D.
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06582888 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Nicotine Addiction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06582888 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06582888 currently recruiting?
Yes, NCT06582888 is actively recruiting participants. Contact the research team at vrstudy@health.ucsd.edu for enrollment information.
Where is the NCT06582888 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06582888 clinical trial?
NCT06582888 is sponsored by University of California, San Diego. The principal investigator is Kelly Courtney, Ph.D. at University of California, San Diego. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.