RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-19
Study Completion:2028-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06582888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Persons, aged 22+
  4. 4. Ability to take oral medication and be willing to adhere to the dosing regimen
  5. 5. For participants able to become pregnant: use of highly effective contraception during study enrollment
  6. 6. Current daily tobacco use (use on 7 days per week, on average, ≥5 cigarettes per day, in the previous 3 months)
  7. 7. Tobacco use history ≥3 years
  8. 8. Endorsement of past week nicotine craving
  1. 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. 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. 3. Current suicidal ideation or history of suicide attempt or self-mutilatory acts in the past 12 months
  4. 4. Other recreational drug use in the past 30 days (besides alcohol and cannabis) verified by oral and urine fluid toxicology
  5. 5. Visual/vestibular problems that may make task completion difficult (i.e., motion sickness, difficulty balancing, blindness)
  6. 6. Treatment seeking for tobacco use disorder/intent to quit within 30 days

Contacts and Locations

Study Contact

Kelly Coutrney, Ph.D
CONTACT
‪619-348-5866‬
kecourtney@health.ucsd.edu
Norma Castro, MA
CONTACT
661-303-4818
nocastro@health.ucsd.edu

Study Locations (Sites)

University California, San Diego
San Diego, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-19
Study Completion Date2028-08-15

Study Record Updates

Study Start Date2024-11-19
Study Completion Date2028-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Nicotine Addiction
  • Craving