Using e-cigarettes to help smokers with opioid use disorder reduce smoking
Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT05722561 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are actively trying to quit smoking or have recently used other tobacco products may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York and 1 other locations
- 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
- Principal investigator: Omar El-Shahawy — NYU Langone Health
- Study coordinator: Omar El-Shahawy, MD, MPH, PhD
- Email: Omar.ElShahawy@nyulangone.org
- Phone: 646-501-3587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.