Methadone-Maintained Smokers Switching to E-Cigarettes

Nicotine Dependence Clinical Trial

— SHINE  

Official title:

Methadone-Maintained Smokers Switching to E-Cigarettes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206435
• Other study ID #: 1702236
• Secondary ID: R01DA052907
• Status: Recruiting
• Phase: Phase 4
• Start date: March 31, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Butler Hospital
• Contact: Ana Abrantes, PhD
• Phone: 401-455-6200
• Email: ana_abrantes[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Electronic Cigarette
Electronic Cigarettes are provided to replace tobacco cigarettes
• Nicotine Lozenge
Nicotine Lozenges are provided to replace tobacco cigarettes

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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