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

NCT05722561 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Nicotine Replacement Product

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

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.

Sponsors & Collaborators

Principal Investigators

  • Omar El-Shahawy · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-08
Primary Completion
2026-11-01
Completion
2027-03-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05722561 on ClinicalTrials.gov