E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-75
SponsorNYU Langone Health

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Does not speak English or Spanish

Are pregnant or breastfeeding

Not able to provide consent

Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)

Trial design

Treatments tested in this trial

  • Telehealth Motivational Counseling
  • Nicotine Replacement Product
  • National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).

Treatment groups

302 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NYU Langone Health

Lead sponsor

National Institutes of Health (NIH)

Collaborator