E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
Key facts
- Who runs it
- NYU Langone Health
- Where
- New York and The Bronx, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 302 people, planned
- Started
- 8 Aug 2024
- Expected to end
- 30 Apr 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Telehealth Motivational Counseling
- Nicotine Replacement Product
- National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
- Record updated
- 9 November 2026
Who can take part
- Age
- 21 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 75 years old?
Where in United States
- NYU Langone HealthNew York, United StatesContact: Omar El-ShahawyTaking people
- Albert Einstein College of MedicineThe Bronx, United StatesContact: Shadi Nahvi, MD (principal investigator)Not yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Electronic CigaretteTreatment being tested
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).
Treatment: Telehealth Motivational Counseling and National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
- Nicotine Replacement TherapyExisting treatment, for comparison
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
Treatment: Telehealth Motivational Counseling and Nicotine Replacement Product
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
- Fit questions
- Built from NCT05722561, who can take part
- Record updated
- 9 November 2026