Clinical trial NCT05722561: E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
Official title: Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Opioid Use Disorder
Cigarette Smoking
Keywords: cigarettes
smoking
smoking reduction
OUD
OUDTP
Buprenorphine
Methadone
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-02-10
Enrollment: 302
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
timeFrame: Up to Visit 5 (Day 56)
Secondary outcomes:
measure: Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
timeFrame: Month 6
measure: Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up
timeFrame: From Visit 5 (Day 56) up to Month 6
measure: Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
timeFrame: Baseline, Visit 5 (Day 56)
measure: Change from Baseline in Self-Reported CPD at Month 6
timeFrame: Baseline, Month 6
measure: Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
timeFrame: Baseline, Visit 5 (Day 56)
measure: Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up
timeFrame: Baseline, Month 6
measure: Number of Respiratory Symptoms Reported at Baseline
timeFrame: Baseline
measure: Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)
timeFrame: Visit 5 (Day 56)
measure: Number of Respiratory Symptoms Reported at Month 6 Follow-up
timeFrame: Month 6
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Omar El-Shahawy
role: PRINCIPAL_INVESTIGATOR
References: