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E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
NCT05722561 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Telehealth Motivational Counseling
- DRUG Nicotine Replacement Product
- DEVICE National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
Study Locations (2)
New York
- NYU Langone Health — New York
- Albert Einstein College of Medicine — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2024-08-08 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05722561
The ClinicalTrials.gov registry entry for NCT05722561 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions — of which Telehealth Motivational Counseling is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05722561 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05722561 about?
NCT05722561 is a clinical study titled "E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder". 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 ...
What is the current status of trial NCT05722561?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 302 participants. The study started on 2024-08-08. Estimated completion is 2027-03-01.
What conditions does trial NCT05722561 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Cigarette Smoking. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05722561?
The interventions under investigation include: Telehealth Motivational Counseling (BEHAVIORAL), Nicotine Replacement Product (DRUG), National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05722561?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05722561 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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