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

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 Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Cigarette Smoking
• Intervention / Treatment: Device: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).; Drug: Nicotine Replacement Product; Behavioral: Telehealth Motivational Counseling

• Study Type: Interventional
• Enrollment (Estimated): 302
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Omar El-Shahawy, MD, MPH, PhD; Phone Number: 646-501-3587; Email: Omar.ElShahawy@nyulangone.org
• Study Contact Backup: Name: Mohsen Abbasi, MD, MPH; Phone Number: 646-501-3581; Email: Mohsen.Abbasikangevari@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Omar El-Shahawy; Phone Number: 646-501-3587; Email: Omar.ElShahawy@nyulangone.org
    • The Bronx, New York, United States, 10461
      • Not yet recruiting
      • Albert Einstein College of Medicine
      • Principal Investigator: Shadi Nahvi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nicotine Replacement Therapy; Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).	Drug: Nicotine Replacement Product; Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.; 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, 6), 15~20 minutes each.
Experimental: Electronic Cigarette; Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).	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.; 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, 6), 15~20 minutes each.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Omar El-Shahawy, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: smoking; Methadone; smoking reduction; Buprenorphine; cigarettes; OUD; OUDTP
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Tobacco Smoking; Tobacco Use; Opioid-Related Disorders; Smoking; Cigarette Smoking; Smoking Reduction; Therapeutics; Tobacco Use Cessation Devices
• Other Study ID Numbers: 22-00661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No