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

Phase 2RecruitingNCT05722561

NYU Langone Health302 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

302

Conditions

Opioid Use Disorder Cigarette Smoking

Interventions

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

NYU Langone Health

New York, New York, United States

RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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