Using virtual reality to assess and treat tobacco addiction

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

This study is testing if a medication called varenicline can help daily tobacco users in San Diego reduce their cravings by using virtual reality to expose them to smoking cues.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06582888 on ClinicalTrials.gov

What this trial studies

This project aims to enroll 200 daily tobacco users aged 22 and older from the San Diego area to evaluate the effectiveness of varenicline in reducing nicotine cravings. Participants will undergo a virtual reality nicotine cue exposure assessment and will be randomized to receive either varenicline or a placebo. After an eight-day titration period, participants will be reassessed using the same virtual reality paradigm and followed up with mobile assessments for short-term nicotine use behaviors over 30 days. The study seeks to establish a connection between virtual reality assessments and treatment outcomes for tobacco use disorder.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older who are daily tobacco users with a history of nicotine craving.

Not a fit: Patients with contraindications to varenicline or severe health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel approach to treating nicotine addiction by utilizing virtual reality as a biomarker for treatment efficacy.

How similar studies have performed: While the use of virtual reality in addiction treatment is emerging, this specific approach is novel and has not been extensively tested in prior studies.

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

Where this trial is running

San Diego, California

• University California, San Diego — San Diego, California, United States (Recruiting)

Study contacts

• Principal investigator: Kelly Courtney, Ph.D. — University of California, San Diego
• Study coordinator: Research Coordinator

Conditions Nicotine Addiction; Craving