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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

Telehealth Motivational Counseling

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.

DRUG

Nicotine Replacement Product

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

DEVICE

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

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

Locations (2)

NYU Langone Health
New York, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States