Menu
Recruiting NCT05722561

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

Phase II Interventional Opioid Use Disorder Cigarette Smoking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telehealth Motivational Counseling, Nicotine Replacement Product, National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC)..
Who it may be relevant to
Registry conditions: Opioid Use Disorder, Cigarette Smoking. Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

Overview

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.

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.

Primary outcome measures

  • 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)]
Secondary outcome measures (9)
  • Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up [Time frame: Month 6]
  • Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up [Time frame: From Visit 5 (Day 56) up to Month 6]
  • Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5) [Time frame: Baseline, Visit 5 (Day 56)]
  • Change from Baseline in Self-Reported CPD at Month 6 [Time frame: Baseline, Month 6]
  • Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5) [Time frame: Baseline, Visit 5 (Day 56)]
  • Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up [Time frame: Baseline, Month 6]
  • Number of Respiratory Symptoms Reported at Baseline [Time frame: Baseline]
  • Number of Respiratory Symptoms Reported at End of Treatment (Visit 5) [Time frame: Visit 5 (Day 56)]
  • Number of Respiratory Symptoms Reported at Month 6 Follow-up [Time frame: Month 6]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • NYU Langone Health — New York
  • Albert Einstein College of Medicine — The Bronx

Identifiers

NCT: NCT05722561 · 22-00661

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗