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

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 Overview

• Status: Recruiting
• Conditions: Craving; Nicotine Addiction
• Intervention / Treatment: Drug: Placebo; Drug: Varenicline Tartrate

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 858-480-1251; Email: vrstudy@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Recruiting
      • University California, San Diego
      • Principal Investigator: Kelly Courtney, Ph.D.
      • Contact: Research Coordinator; Phone Number: 858-480-1251; Email: vrstudy@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Varenicline Tartrate; varenicline (target dose 1mg twice daily); Other Names: Varenicline
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.	Drug: Placebo; matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Kelly Courtney, Ph.D., University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2028

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Quinoxalines; Varenicline
• Other Study ID Numbers: R01DA058665 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Psychophysiology, mental health, and substance use de-identified data listed above sufficient in quality to validate and replicate the research findings described in the aims will be deposited to the National Addiction & HIV Data Archive Program (NAHDAP) repository. For specific variables where small sample sizes may allow for easy re-identification of research participants, only summarized data will be made available.
• IPD Sharing Time Frame: Data will become available 2025-2028
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No