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NCT Number: NCT06582888

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

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.

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Key information

Conditions

Nicotine Addiction Chemically-Induced Disorders Craving Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University California, San Diego

San Diego, California, 92093, United States

Location status: Recruiting

Location contact

Kelly Courtney, Ph.D.

PRINCIPAL_INVESTIGATOR

Research Coordinator

CONTACT

[email protected]

858-480-1251

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

varenicline tartrate

Drug

varenicline (target dose 1mg twice daily)

Other names: Varenicline

Placebo

Drug

matched placebo

Primary outcomes

  1. 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

    Eye gaze fixation time to active versus neutral cues from the "NTP Cue VR Paradigm"

  2. Nicotine craving

    Time frame: during each in-person session, at baseline and on average 8 days post baseline assessment

    Assessed via the Tobacco Craving Questionnaire - Short-Form

  3. Nicotine craving

    Time frame: through study completion, an average of 30 days

    Assessed via visual analogue scales (VR paradigm and mobile surveys)

  4. Nicotine use episodes

    Time frame: during each in-person session, at baseline and on average 8 days post baseline assessment

    Assessed via the Timeline Followback

  5. Nicotine use episodes

    Time frame: through study completion, an average of 30 days

    Assessed via participant fill-in on mobile surveys

Study contacts

Contact information is provided by the study sponsor or research team.

Research Coordinator

CONTACT

[email protected]

858-480-1251

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: VR

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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