Status:
RECRUITING
Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Addiction
Craving
Eligibility:
All Genders
22+ years
Phase:
EARLY_PHASE1
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06582888
Start Date
November 19 2024
End Date
August 15 2028
Last Update
November 22 2024
Active Locations (1)
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1
University California, San Diego
San Diego, California, United States, 92093