Clinical trial NCT05206435: Methadone-Maintained Smokers Switching to E-Cigarettes
Official title: Methadone-Maintained Smokers Switching to E-Cigarettes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Nicotine Dependence
Electronic Cigarette Use
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-01-25
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Nicotine Exposure
timeFrame: 6 weeks
measure: FVC Lung Functioning
timeFrame: 6 weeks
measure: FEV1 Lung Functioning
timeFrame: 6 weeks
measure: FEV1/FVC Ratio Lung Functioning
timeFrame: 6 weeks
measure: Smoking Behavior and Experiences
timeFrame: 6 weeks
measure: Nicotine Exposure for Complete Switchers
timeFrame: 6 weeks
measure: FVC Lung Functioning for Complete Switchers
timeFrame: 6 weeks
measure: FEV1 Lung Functioning for Complete Switchers
timeFrame: 6 weeks
measure: FEV1/FVC Ratio Lung Functioning for Complete Switchers
timeFrame: 6 weeks
measure: Smoking Behavior and Experiences for Complete Switchers
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References: