NCT05206435

Methadone-Maintained Smokers Switching to E-Cigarettes

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. 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. All participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT. This study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.

Conditions

• Nicotine Dependence
• Electronic Cigarette Use

Interventions

Type	Name	Description
DRUG	Electronic Cigarette	Electronic Cigarettes are provided to replace tobacco cigarettes
DRUG	Nicotine Lozenge	Nicotine Lozenges are provided to replace tobacco cigarettes

Timeline

• Start date: 2022-03-31
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-01-25
• Last updated: 2024-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study