Actively Recruiting

Phase 2
Age: 21Years - 75Years
All Genders
NCT05722561

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

Led by NYU Langone Health · Updated on 2026-03-11

302

Participants Needed

2

Research Sites

133 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently smokes 5 or more combustible cigarettes per day
  • Age 21 years or older
  • Diagnosed with Opioid Use Disorder
  • In methadone or buprenorphine treatment for 12 weeks or more
  • Stable methadone or buprenorphine dose for at least two weeks
  • Interested in reducing combustible cigarette smoking
  • Owns or has regular access to a mobile phone
  • Able to provide an additional contact for follow-up
Not Eligible

You will not qualify if you...

  • Does not speak English or Spanish
  • Pregnant or breastfeeding
  • Unable to provide consent
  • Used tobacco products other than combustible cigarettes in the past 2 weeks
  • Currently trying to quit combustible cigarette smoking
  • Has severe chronic obstructive pulmonary disease or asthma with recent hospitalization or intubation
  • Has current major depressive or manic episode, psychotic disorder, recent suicide attempt or hospitalization, or current suicidal ideation with plan or intent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

2

Albert Einstein College of Medicine

The Bronx, New York, United States, 10461

Not Yet Recruiting

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Research Team

O

Omar El-Shahawy, MD, MPH, PhD

CONTACT

M

Mohsen Abbasi, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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