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

Early Phase 1

Recruiting

• Conditions: Nicotine Addiction; Craving
• Interventions: Drug: Varenicline Tartrate; Drug: Placebo

• Registration Number: NCT06582888
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Status Verified: 2024-11
• Study Start: 2024-11-19
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2028-08-15
• Study Completion: 2028-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline	Varenicline Tartrate	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	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 Measures

Name	Time	Method
Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment	during each in-person session, at baseline and on average 8 days post baseline assessment	Eye gaze fixation time to active versus neutral cues from the \"NTP Cue VR Paradigm\"
Nicotine craving	through study completion, an average of 30 days	Assessed via visual analogue scales (VR paradigm and mobile surveys)
Nicotine use episodes	through study completion, an average of 30 days	Assessed via participant fill-in on mobile surveys

Trial Locations

Locations (1)

University California, San Diego; 🇺🇸 San Diego, California, United States