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NCT Number: NCT05722561

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 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.

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Key information

Conditions

Opioid Use Disorder Behavior Chemically-Induced Disorders Cigarette Smoking Health Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Smoking Smoking Reduction Substance-Related Disorders Tobacco Smoking Tobacco Use

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NYU Langone Health, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • Currently engaged in an attempt to quit CC smoking
  • Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)
  • Reports current major depressive or manic episode, current psychotic disorder, past-year suicide attempt or psychiatric hospitalization, or current suicidal ideation with plan or intent.

Treatment and study plan

Telehealth Motivational Counseling

Behavioral

At baseline, after randomization, participants will receive their first telehealth session (20~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Four additional sessions will be delivered (weeks 2, 3, 4, 6), 15~20 minutes each.

Nicotine Replacement Product

Drug

Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.

National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).

Device

Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.

Primary outcomes

  1. Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)

    Time frame: Up to Visit 5 (Day 56)

    Verified by exhaled carbon-monoxide (eCO) level.

Secondary outcomes

  1. Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up

    Time frame: Month 6

    Verified by exhaled carbon-monoxide (eCO) level.

  2. Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up

    Time frame: From Visit 5 (Day 56) up to Month 6

    Verified by exhaled carbon-monoxide (eCO) level.

  3. Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)

    Time frame: Baseline, Visit 5 (Day 56)

    Verified by exhaled carbon-monoxide (eCO) level.

  4. Change from Baseline in Self-Reported CPD at Month 6

    Time frame: Baseline, Month 6

    Verified by exhaled carbon-monoxide (eCO) level.

  5. Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)

    Time frame: Baseline, Visit 5 (Day 56)

    8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period.

  6. Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up

    Time frame: Baseline, Month 6

    8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period.

  7. Number of Respiratory Symptoms Reported at Baseline

    Time frame: Baseline

  8. Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)

    Time frame: Visit 5 (Day 56)

  9. Number of Respiratory Symptoms Reported at Month 6 Follow-up

    Time frame: Month 6

Study contacts

Contact information is provided by the study sponsor or research team.

Mohsen Abbasi, MD, MPH

CONTACT

[email protected]

646-501-3581

Omar El-Shahawy, MD, MPH, PhD

CONTACT

[email protected]

646-501-3587

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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