E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
- Conditions
- Cigarette SmokingOpioid Use Disorder
- Interventions
- Behavioral: Telehealth Motivational CounselingDevice: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
- Registration Number
- NCT05722561
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 302
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nicotine Replacement Therapy Telehealth Motivational Counseling Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). Electronic Cigarette Telehealth Motivational Counseling Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC). Nicotine Replacement Therapy Nicotine Replacement Product Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). Electronic Cigarette National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).
- Primary Outcome Measures
Name Time Method Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5) Up to Visit 5 (Day 56) Verified by exhaled carbon-monoxide (eCO) level.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5) Baseline, Visit 5 (Day 56) Verified by exhaled carbon-monoxide (eCO) level.
Number of Respiratory Symptoms Reported at Month 6 Follow-up Month 6 Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up 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.
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up Month 6 Verified by exhaled carbon-monoxide (eCO) level.
Change from Baseline in Self-Reported CPD at Month 6 Baseline, Month 6 Verified by exhaled carbon-monoxide (eCO) level.
Number of Respiratory Symptoms Reported at Baseline Baseline Number of Respiratory Symptoms Reported at End of Treatment (Visit 5) Visit 5 (Day 56) Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up From Visit 5 (Day 56) up to Month 6 Verified by exhaled carbon-monoxide (eCO) level.
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5) 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.
Trial Locations
- Locations (2)
NYU Langone Health
🇺🇸New York, New York, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States