RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-08
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05722561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Currently smokes 5 or more CPD
  2. 2. Age ≥ 21 years
  3. 3. Has a diagnosis of Opioid Use Disorder
  4. 4. In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records
  5. 5. Stable methadone or buprenorphine dose for two weeks via self-report or EHR records
  6. 6. Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit
  7. 7. Own a mobile phone or have regular access to a mobile phone.
  8. 8. Able to provide an additional contact to improve follow-up rates.
  1. 1. Does not speak English or Spanish
  2. 2. Are pregnant or breastfeeding
  3. 3. Not able to provide consent
  4. 4. Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)
  5. 5. Currently engaged in an attempt to quit CC smoking
  6. 6. Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)
  7. 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.

Contacts and Locations

Study Contact

Omar El-Shahawy, MD, MPH, PhD
CONTACT
646-501-3587
Omar.ElShahawy@nyulangone.org
Mohsen Abbasi, MD, MPH
CONTACT
646-501-3581
Mohsen.Abbasikangevari@nyulangone.org

Principal Investigator

Omar El-Shahawy
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

Albert Einstein College of Medicine
Bronx, New York, 10461
United States
NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Omar El-Shahawy, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-08-08
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Cigarette Smoking