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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
Who can join
Ages 21 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Currently smokes 5 or more CPD 2. Age ≥ 21 years 3. Has a diagnosis of Opioid Use Disorder 4. In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records 5. Stable methadone or buprenorphine dose for two weeks via self-report or EHR records 6. Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit 7. Own a mobile phone or have regular access to a mobile phone. 8. Able to provide an additional contact to improve follow-up rates. Exclusion Criteria: 1. Does not speak English or Spanish 2. Are pregnant or breastfeeding 3. Not able to provide consent 4. Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo) 5. Currently engaged in an attempt to quit CC smoking 6. Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months) 7. Reports current major depressive or manic episode, current psychotic disorder, past-year suicide attempt or psychiatric hospitalization, or current suicidal ideation with plan or intent.
About the study
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.
What is being tested
- Telehealth Motivational Counseling (behavioral)
- Nicotine Replacement Product (drug)
- National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). (device)
Sponsor: NYU Langone Health · Participants: 302 · Started: Aug 8, 2024
Contact the study team
- Omar El-Shahawy, MD, MPH, PhD · Phone: 646-501-3587
- Mohsen Abbasi, MD, MPH · Phone: 646-501-3581
Official record on ClinicalTrials.gov — NCT05722561
Locations in the U.S.
| New York | NYU Langone Health, New York Albert Einstein College of Medicine, The Bronx (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.