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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 21 to 75

Using e-cigarettes to help smokers with opioid use disorder reduce smoking

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

Run by NYU Langone Health · NCT05722561 · Data updated 2026-11-12

This study is testing if using e-cigarettes can help people with opioid use disorder who smoke to cut down on their cigarette use more effectively than just getting counseling and nicotine replacement therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Ages21 Years to 75 Years
SexAll
Enrollment302 (estimated)
SponsorNYU Langone Health
Academic / other
Locations2 sites (New York, New York and 1 other locations)
StatusRecruiting
StartedAugust 8, 2024
Main results expectedFebruary 10, 2027
Study endsApril 30, 2027
Registry record updatedNovember 9, 2026
Trial IDNCT05722561 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 21 and older who smoke at least 5 cigarettes per day and are currently receiving treatment for opioid use disorder.

Probably not a fit

Patients who are actively trying to quit smoking or have recently used other tobacco products may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized controlled trial compares the effectiveness of electronic cigarettes to telehealth motivational counseling combined with nicotine replacement therapy for reducing combustible cigarette smoking among individuals with opioid use disorder. Participants must be enrolled in opioid use disorder treatment programs and have a history of smoking. The study aims to provide an additional tool for tobacco harm reduction in this vulnerable population, which has historically faced challenges in achieving smoking cessation. The trial will assess the impact of these interventions on smoking reduction over a specified period.

Why it matters

Potential benefit: If successful, this approach could significantly reduce smoking rates among patients with opioid use disorder, improving their overall health outcomes.

How similar studies have gone: While the use of e-cigarettes for smoking cessation is a growing area of interest, this specific approach targeting opioid use disorder patients is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • NYU Langone Health
    New York, New York, United States     Recruiting
  • Albert Einstein College of Medicine
    The Bronx, New York, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.