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
1 other identifier
interventional
302
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
August 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 11, 2026
March 1, 2026
2.2 years
February 1, 2023
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
Month 6
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
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
Baseline, Visit 5 (Day 56)
Change from Baseline in Self-Reported CPD at Month 6
Baseline, Month 6
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
Baseline, Visit 5 (Day 56)
- +4 more secondary outcomes
Study Arms (2)
Electronic Cigarette
EXPERIMENTALParticipants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).
Nicotine Replacement Therapy
ACTIVE COMPARATORParticipants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
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.
Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.
Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institutes of Health (NIH)collaborator
Study Sites (2)
NYU Langone Health
New York, New York, 10016, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar El-Shahawy
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 10, 2023
Study Start
August 8, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data and researchers who provide a methodologically sound proposal will be granted access to the data upon reasonable request. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[Omar.ElShahawy@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.