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

Conditions

• Cigarette Smoking
• Opioid Use Disorder

Eligibility Criteria

Sex

ALL

Age

21 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Telehealth Motivational Counseling — BEHAVIORAL
  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 — DRUG
  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). — DEVICE
  Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.

Study Details

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.

Key Dates

Start date

Aug 8, 2024

Status verified

Mar 2026

Primary completion

Nov 1, 2026

Completion

Mar 1, 2027

Study Design

Enrollment

302 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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).

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

• Omar El-Shahawy, MD, MPH, PhD
  646-501-3587
  [email protected]
• Mohsen Abbasi, MD, MPH
  646-501-3581
  [email protected]

Locations (2)

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