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Not Yet Recruiting NCT05722561

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

Conditions: Opioid Use Disorder, Cigarette Smoking

Sex: All
Ages: 21 Years – 75 Years
Phase: PHASE2
Enrollment: 350
Sponsor: NYU Langone Health

Location: United States

Summary

The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) with 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:Currently smokes 5 or more CPDAge ≥ 21 yearsHas a diagnosis of Opioid Use DisorderIn OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR recordsStable methadone or buprenorphine dose for two weeks via self-report or EHR recordsInterested in reducing combustible cigarette (CC) smoking but not necessarily trying to quitOwn 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 SpanishAre pregnant or breastfeedingNot able to provide consentUsed tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)Currently engaged in an attempt to quit CC smokingReports 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05722561). StuddyBuddy aggregates publicly available trial information.