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

Study Overview
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Brief Summary
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The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) with 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.

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

Conditions
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Opioid Use Disorder, Cigarette Smoking

Intervention / Treatment
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* Behavioral: Telehealth Motivational Counseling
* Drug: Nicotine Replacement Product
* Device: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Cigarette<br>Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 6 weeks plus the standardized research e-cigarette (SREC). | Behavioral: Telehealth Motivational Counseling<br>* 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, and 6), 15 20 minutes each.<br>Device: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).<br>* Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.<br>|
| Active Comparator: Nicotine Replacement Therapy<br>Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). | Behavioral: Telehealth Motivational Counseling<br>* 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, and 6), 15 20 minutes each.<br>Drug: Nicotine Replacement Product<br>* Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5) | Verified by exhaled carbon-monoxide (eCO) level. | Up to Visit 5 (Day 56) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up | Verified by exhaled carbon-monoxide (eCO) level. | Month 6 | 
| Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up | Verified by exhaled carbon-monoxide (eCO) level. | From Visit 5 (Day 56) up to Month 6 | 
| Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5) | Verified by exhaled carbon-monoxide (eCO) level. | Baseline, Visit 5 (Day 56) | 
| Change from Baseline in Self-Reported CPD at Month 6 | Verified by exhaled carbon-monoxide (eCO) level. | Baseline, Month 6 | 
| Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5) | 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. | Baseline, Visit 5 (Day 56) | 
| Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up | 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. | Baseline, Month 6 | 
| Number of Respiratory Symptoms Reported at Baseline |  | Baseline | 
| Number of Respiratory Symptoms Reported at End of Treatment (Visit 5) |  | Visit 5 (Day 56) | 
| Number of Respiratory Symptoms Reported at Month 6 Follow-up |  | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarettes, smoking, smoking reduction, OUD, OUDTP, Buprenorphine, Methadone