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Completed
NCT05206435
Methadone-Maintained Smokers Switching to E-Cigarettes
Conditions: Nicotine Dependence, Electronic Cigarette Use
Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 183
Sponsor: Butler Hospital
Location: Butler Hospital Providence Rhode Island
Summary
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
Eligibility Criteria
Inclusion Criteria:
* moderate to heavy cigarette smokers (10 cigarettes/day for \> 1 yr; breath CO \> 10 ppm)
* have been receiving methadone for at least three months
* attend at least weekly to receive methadone dose
* speak English
* have a telephone or access to a telephone
* are available over the next 6 weeks
* are interested in switching to either electronic cigarettes or nicotine replacement therapy
Exclusion Criteria:
* use of ECs on \> 2 of the past 30 days
* currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT)
* have unstable psychiatric conditions
* have near-daily or daily use of marijuana
* are pregnant
* had a cardiovascular event in the last month
* daily medication for asthma or COPD
Source: ClinicalTrials.gov (NCT05206435). StuddyBuddy aggregates publicly available trial information.