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

ConditionsOpioid Use Disorder Cigarette Smoking

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

302 Participants

are divided into 2 treatment groups

Group A: Electronic CigaretteExperimental treatment 2 interventions

Group B: Nicotine Replacement TherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

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