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

NCT ID: NCT06582888

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-19
• Study Completion Date: 2028-08-15

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.

Conditions

Nicotine Addiction; Craving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Varenicline

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.

Group Type: EXPERIMENTAL

Varenicline Tartrate

Intervention Type: DRUG

varenicline (target dose 1mg twice daily)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matched placebo

Interventions

Varenicline Tartrate

varenicline (target dose 1mg twice daily)

Intervention Type: DRUG

Placebo

matched placebo

Intervention Type: DRUG

Other Intervention Names

Varenicline

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Kelly Courtney

Assistant Adjunct Professor, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University California, San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelly Coutrney, Ph.D

Role: CONTACT

kecourtney@health.ucsd.edu

‪619-348-5866‬

Norma Castro, MA

Role: CONTACT

nocastro@health.ucsd.edu

661-303-4818

Facility Contacts

Norma Castro, MA

Role: primary

nocastro@health.ucsd.edu

661-303-4818

Other Identifiers

R01DA058665

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA058665

Identifier Type: NIH

Identifier Source: org_study_id

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