Recruiting
Early Phase 1

Attentional Bias

Sponsor:

UCLA

Code:

NCT06582888

Conditions

Nicotine Addiction

Craving

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Varenicline Tartrate

Placebo

Study Details

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 ID

NCT06582888

Start date

Nov 19, 2024

Status verified date

Mar, 2026

Completion date

Aug 15, 2028

Anticipated

Primary completion date

Aug 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

Varenicline Tartrate

varenicline (target dose 1mg twice daily)

Placebo

matched placebo

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Research Coordinator

858-480-1251vrstudy@health.ucsd.edu

Locations

University California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Research Coordinator

858-480-1251vrstudy@health.ucsd.edu

Principal Investigator:

Kelly Courtney, Ph.D.

More Information

Sponsor

University of California, San Diego

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-03-16.