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Completed

NCT Number: NCT05206435

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Electronic Cigarette Use Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Cigarette

Drug

Electronic Cigarettes are provided to replace tobacco cigarettes

Nicotine Lozenge

Drug

Nicotine Lozenges are provided to replace tobacco cigarettes

Primary outcomes

  1. Nicotine Exposure

    Time frame: 6 weeks

    Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-weeks.

  2. FVC Lung Functioning

    Time frame: 6 weeks

    Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks.

  3. FEV1 Lung Functioning

    Time frame: 6 weeks

    Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks.

  4. FEV1/FVC Ratio Lung Functioning

    Time frame: 6 weeks

    Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks.

  5. Smoking Behavior and Experiences

    Time frame: 6 weeks

    Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks.

  6. Nicotine Exposure for Complete Switchers

    Time frame: 6 weeks

    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.

  7. FVC Lung Functioning for Complete Switchers

    Time frame: 6 weeks

    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.

  8. FEV1 Lung Functioning for Complete Switchers

    Time frame: 6 weeks

    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.

  9. FEV1/FVC Ratio Lung Functioning for Complete Switchers

    Time frame: 6 weeks

    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.

  10. Smoking Behavior and Experiences for Complete Switchers

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: SHINE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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