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

NCT06582888 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: R01DA058665
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment

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

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

• Nicotine craving

  Assessed via the Tobacco Craving Questionnaire - Short-Form

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

• Nicotine craving

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

  through study completion, an average of 30 days

• Nicotine use episodes

  Assessed via the Timeline Followback

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

• Nicotine use episodes

  Assessed via participant fill-in on mobile surveys

  through study completion, an average of 30 days

Study Arms (2)

Varenicline

EXPERIMENTAL

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.

Drug: Varenicline Tartrate

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Varenicline Tartrate DRUG

varenicline (target dose 1mg twice daily)

Also known as: Varenicline

Varenicline

Placebo DRUG

matched placebo

Placebo

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Kelly Courtney, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Adjunct Professor, Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 3, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: Data will become available 2025-2028
• Access Criteria: Standard procedures of the NAHDAP will be followed for determining the best level of access (public or restricted) based on review of disclosure risk by ICPSR.

Locations

US (1)