Recruiting
Phase 2

E-Cigarettes

Sponsor:

NYU Langone Health

Code:

NCT05722561

Conditions

Opioid Use Disorder

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Telehealth Motivational Counseling

Nicotine Replacement Product

National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).

Study Details

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.

Conditions

Opioid Use Disorder

Cigarette Smoking

Study ID

NCT05722561

Start date

Aug 8, 2024

Status verified date

Mar, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

302 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

active comparator: Nicotine Replacement Therapy

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

Interventions

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.

Nicotine Replacement Product

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

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.

Primary outcome measure

  • Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5) [ Time Frame: Up to Visit 5 (Day 56) ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • cigarettes
  • smoking
  • smoking reduction
  • OUD
  • OUDTP
  • Buprenorphine
  • Methadone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-11.