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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Albert Einstein College of Medicine
NOT_YET_RECRUITING
The Bronx
Contact Information
Primary
Omar El-Shahawy, MD, MPH, PhD
Omar.ElShahawy@nyulangone.org
646-501-3587
Backup
Mohsen Abbasi, MD, MPH
Mohsen.Abbasikangevari@nyulangone.org
646-501-3581
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 302
Treatments
Experimental: Electronic Cigarette
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).
Active_comparator: Nicotine Replacement Therapy
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov