Methadone-Maintained Smokers Switching to E-Cigarettes

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Butler Hospital
• Treatments: Nicotine

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