Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

What this Trial Is About

Researchers are evaluating the effectiveness of electronic cigarettes compared to telehealth motivational counseling combined with nicotine replacement therapy (NRT) in reducing smoking among people with opioid use disorder (OUD) who are receiving methadone or buprenorphine treatment. This study focuses on a population with a high rate of cigarette smoking and limited success with tobacco treatment, aiming to find additional tools for harm reduction. It is an open-label, randomized controlled trial sponsored by NYU Langone Health. Participants are randomly assigned to one of two groups. One group receives telehealth motivational counseling for five weeks along with a standardized research electronic cigarette (SREC) to use freely as a replacement for combustible cigarettes. The other group receives telehealth motivational counseling plus combination NRT using patches and lozenges, following product directions. Counseling sessions start at baseline and continue weekly, with the first session lasting about 20-25 minutes and subsequent sessions about 15-20 minutes each. During the study, participants will be monitored through five visits up to Day 56, with a follow-up at six months. Researchers will measure the percentage of participants who achieve complete reduction in cigarettes smoked per day, changes in self-reported smoking rates, health-related quality of life survey scores, and respiratory symptoms. The study includes assessments at baseline, the end of intervention, and six months later to evaluate the impact and safety of the interventions in this vulnerable population.

E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder