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

NYU Langone Health

Status and phase: Enrolling; Phase 2

Conditions: Cigarette Smoking; Opioid Use Disorder

Treatments: Device: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).; Behavioral: Telehealth Motivational Counseling; Drug: Nicotine Replacement Product

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05722561

22-00661

Details and patient eligibility

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Currently smokes 5 or more CPD
2. Age ≥ 21 years
3. Has a diagnosis of Opioid Use Disorder
4. In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records
5. Stable methadone or buprenorphine dose for two weeks via self-report or EHR records
6. Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit
7. Own a mobile phone or have regular access to a mobile phone.
8. Able to provide an additional contact to improve follow-up rates.

Exclusion criteria

1. Does not speak English or Spanish
2. Are pregnant or breastfeeding
3. Not able to provide consent
4. Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)
5. Currently engaged in an attempt to quit CC smoking
6. Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Electronic Cigarette

Experimental group

Description:

Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).

Treatment:

Behavioral: Telehealth Motivational Counseling

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

Nicotine Replacement Therapy

Active Comparator group

Description:

Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).

Treatment:

Drug: Nicotine Replacement Product

Behavioral: Telehealth Motivational Counseling