NCT05722561

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus telehealth motivational counseling with combination nicotine replacement therapy (NRT) + telehealth counseling on combustible cigarettes smoking reduction among persons with opioid use disorder (OUD) in methadone and buprenorphine treatment programs (opioid use disorder treatment programs (OUDTP)). OUDTP patients are a population with exceptionally high combustible cigarettes smoking burden and yet limited success in achieving meaningful clinical outcomes in tobacco treatment. If effective, electronic cigarettes would provide an additional tool for tobacco harm reduction among this difficult-to-treat vulnerable population.

Conditions

• Opioid Use Disorder
• Cigarette Smoking

Interventions

Type	Name	Description
BEHAVIORAL	Telehealth Motivational Counseling	At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Four additional sessions will be delivered (weeks 2, 3, 4, 6), 15\~20 minutes each.
DRUG	Nicotine Replacement Product	Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.
DEVICE	National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).	Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.

Timeline

• Start date: 2024-08-08
• Primary completion: 2026-11-01
• Completion: 2027-03-01
• First posted: 2023-02-10
• Last updated: 2026-03-11

Locations

2 sites across 1 country: United States