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

Recruiting now · Phase 2

Conditions studied: Opioid Use Disorder, Cigarette Smoking

In brief

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.

Key facts

Study ID

NCT05722561

Run by

NYU Langone Health

People needed

302

Starts

2024-08-08

Expected to finish

2027-03-01

Last updated by the study team

2026-03-11

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently smokes 5 or more CPD
• Age ≥ 21 years
• Has a diagnosis of Opioid Use Disorder
• In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records
• Stable methadone or buprenorphine dose for two weeks via self-report or EHR records
• Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit
• Own a mobile phone or have regular access to a mobile phone.
• Able to provide an additional contact to improve follow-up rates.

You may not qualify if…

• Does not speak English or Spanish
• Are pregnant or breastfeeding
• Not able to provide consent
• Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)
• Currently engaged in an attempt to quit CC smoking
• Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)
• 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.

Where it is running

• NYU Langone Health — New York, New York, United States (enrolling)
• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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