Methadone-Maintained Smokers Switching to E-Cigarettes (SHINE)

Butler Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Nicotine Dependence; Electronic Cigarette Use

Treatments: Drug: Nicotine Lozenge; Drug: Electronic Cigarette

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05206435

1702236

R01DA052907 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Electronic Cigarettes

Active Comparator group

Description:

Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.

Treatment:

Drug: Electronic Cigarette

Nicotine Lozenges

Active Comparator group

Description:

Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.

Treatment:

Drug: Nicotine Lozenge