Methadone-Maintained Smokers Switching to E-Cigarettes

1702236

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.

2022-03-31

2024-06-30

2024-06-30

Recruiting

Early phase I

240

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2023-10-10