Methadone-Maintained Smokers Switching to E-Cigarettes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Methadone-Maintained Smokers Switching to E-Cigarettes

Conditions
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Nicotine Dependence, Electronic Cigarette Use

Intervention / Treatment
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* Drug: Electronic Cigarette
* Drug: Nicotine Lozenge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electronic Cigarettes<br>Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period. | Drug: Electronic Cigarette<br>* Electronic Cigarettes are provided to replace tobacco cigarettes<br>|
| Active Comparator: Nicotine Lozenges<br>Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period. | Drug: Nicotine Lozenge<br>* Nicotine Lozenges are provided to replace tobacco cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine Exposure | Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-weeks. | 6 weeks | 
| FVC Lung Functioning | Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks. | 6 weeks | 
| FEV1 Lung Functioning | Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks. | 6 weeks | 
| FEV1/FVC Ratio Lung Functioning | Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks. | 6 weeks | 
| Smoking Behavior and Experiences | Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks. | 6 weeks | 
| Nicotine Exposure for Complete Switchers | Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-week among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users. | 6 weeks | 
| FVC Lung Functioning for Complete Switchers | Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users. | 6 weeks | 
| FEV1 Lung Functioning for Complete Switchers | Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users. | 6 weeks | 
| FEV1/FVC Ratio Lung Functioning for Complete Switchers | Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users. | 6 weeks | 
| Smoking Behavior and Experiences for Complete Switchers | Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users. | 6 weeks |