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RECRUITING
NCT05722561
PHASE2

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

302

Start Date

2024-08-08

Completion Date

2027-03-01

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

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.

Locations (2)

NYU Langone Health

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States