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

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use; Nicotine Dependence
• Intervention / Treatment: Drug: Electronic Cigarette; Drug: Nicotine Lozenge

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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Use Disorder; Vaping; Therapeutics; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Electronic Nicotine Delivery Systems; Tobacco Use Cessation Devices
• Other Study ID Numbers: 1702236; R01DA052907 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No