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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people who are addicted to nicotine, specifically those who smoke tobacco daily. The researchers want to see if a medication called varenicline can help reduce cravings and smoking behavior. They will enroll 200 participants, aged 22 and older, from the San Diego area who smoke at least five cigarettes a day. Eligible participants must be willing to take oral medication and follow the study procedures, and they should have a history of smoking for at least three years.

During the trial, participants will undergo virtual reality (VR) assessments to measure their responses to nicotine cues before and after taking the medication for eight days. Half of the participants will receive varenicline, while the other half will get a placebo, which looks like the medication but has no active ingredients. After the initial eight days, researchers will continue to follow up with participants through mobile assessments and phone calls for an additional 30 days to observe any changes in their smoking habits. It's important to note that individuals with certain medical conditions, those who are pregnant or nursing, and those who have recently attempted to quit smoking may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• 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