Nicotine Dependence Clinical Trial
— SHINEOfficial title:
Methadone-Maintained Smokers Switching to E-Cigarettes
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Butler Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Butler Hospital | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nicotine Exposure | Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-weeks. | 6 weeks | |
Primary | FVC Lung Functioning | Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks. | 6 weeks | |
Primary | 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 | |
Primary | FEV1/FVC Ratio Lung Functioning | Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks. | 6 weeks | |
Primary | Smoking Behavior and Experiences | Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks. | 6 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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