Using Virtual Reality to Study Attention and Craving in Adults With Tobacco Addiction Comparing Varenicline Medication to Placebo in Daily Smokers

What this Trial Is About

Researchers are evaluating varenicline as a treatment for tobacco use disorder and nicotine craving in adults aged 22 and older who are daily tobacco cigarette users. This early phase 1 clinical trial aims to advance understanding of VR-based attentional bias as a biomarker for tobacco use disorder by comparing varenicline to placebo in a randomized, quadruple-blind study. Participants will be randomly assigned to receive either varenicline or a matched placebo. Those in the varenicline group will undergo an 8-day dose escalation starting at 0.5 mg once daily, increasing to a target dose of 1 mg twice daily by Day 8. Both groups will have assessments using a virtual reality nicotine cue exposure task at baseline and after reaching the target dose. Following in-person testing on Day 9 or up to Day 11 if needed, participants continue their assigned dosing for eight more days while being monitored remotely via mobile assessments. During the study, participants will complete virtual reality tests measuring attentional bias to nicotine cues and report nicotine craving and use episodes at baseline and after treatment. Mobile assessments will track nicotine use behaviors for eight days at the target dose and by phone 30 days later. The primary outcomes include changes in VR attentional bias, nicotine craving, and nicotine use episodes over the study period. Participants are expected to be available for the full duration of the trial to complete all procedures and follow-up assessments.

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