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

Overview

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.

Interventions

• Drug Varenicline Tartrate
  varenicline (target dose 1mg twice daily)
• Drug Placebo
  matched placebo

Primary outcome measures

• Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment [Time frame: during each in-person session, at baseline and on average 8 days post baseline assessment]
• Nicotine craving [Time frame: during each in-person session, at baseline and on average 8 days post baseline assessment]
• Nicotine craving [Time frame: through study completion, an average of 30 days]
• Nicotine use episodes [Time frame: during each in-person session, at baseline and on average 8 days post baseline assessment]
• Nicotine use episodes [Time frame: through study completion, an average of 30 days]

Eligibility criteria

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following 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
• Endorsement of past week nicotine craving

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Basic science

Study locations

United States · 1 center

• University California, San Diego — San Diego

Identifiers

NCT: NCT06582888 · R01DA058665 · R01DA058665

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗