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NCT05722561 · ClinicalTrials.gov registry record · Phase 2
E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
A Phase 2 study of Opioid Use Disorder and Cigarette Smoking, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 302
- Enrollment target
- 2
- Study locations
NCT05722561 is a Phase 2 study of Opioid Use Disorder and Cigarette Smoking that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 302 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05722561, a Phase 2 study of Opioid Use Disorder and Cigarette Smoking, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 302 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (94% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
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.
NCT05722561 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
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.
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).
Who is sponsoring clinical trial NCT05722561?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.