Actively Recruiting

Early Phase 1
Age: 22Years +
All Genders
NCT06582888

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

Led by University of California, San Diego · Updated on 2026-03-16

200

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

Sponsors

U

University of California, San Diego

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provision of signed and dated informed consent form
  • Willingness to comply with all study procedures and be available for the entire study
  • Age 22 years or older
  • Ability and willingness to take oral medication following the dosing schedule
  • Use of highly effective contraception during study enrollment for participants able to become pregnant
  • Current daily tobacco use, averaging at least 5 cigarettes per day on 7 days per week over the last 3 months
  • Tobacco use history of 3 years or more
  • Reported nicotine craving in the past week
Not Eligible

You will not qualify if you...

  • History of serious allergic reactions or skin reactions to varenicline
  • Severe kidney problems, seizures, severe cardiovascular disease, chronic or severe nausea, Stevens-Johnson syndrome, erythema multiforme
  • Pregnancy or currently nursing
  • History or treatment of neurological disorders or severe head trauma with loss of consciousness over 2 minutes
  • Current severe psychiatric disorders other than tobacco use disorder
  • Suicidal thoughts or attempts, or self-harm in the past 12 months
  • Use of recreational drugs other than alcohol and cannabis in the past 30 days confirmed by toxicology tests
  • Visual or balance problems such as motion sickness or blindness that would make task completion difficult
  • Currently seeking treatment for tobacco use disorder or intending to quit within 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University California, San Diego

San Diego, California, United States, 92093

Actively Recruiting

Loading map...

Research Team

R

Research Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here