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

Sponsor

NYU Langone Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05722561

Collaborator

National Institutes of Health (NIH) (NIH)

350

Enrollment

Location

Arms

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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) 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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder Cigarette Smoking	Behavioral: Telehealth Motivational Counseling Drug: Nicotine Replacement Product Device: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electronic Cigarette 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 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. 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.
Active Comparator: Nicotine Replacement Therapy Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).	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, and 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.

Arm

Intervention/Treatment

Experimental: Electronic Cigarette

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

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.

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.

Active Comparator: Nicotine Replacement Therapy

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

Behavioral: Telehealth Motivational Counseling

Drug: Nicotine Replacement Product

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

Outcome Measures

Primary Outcome Measures

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

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.
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 Self-Reported CPD at End of Intervention (Visit 5) [Baseline, Visit 5 (Day 56)]
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.
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.
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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.