Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05206435
Study type Interventional
Source Butler Hospital
Contact Ana Abrantes, PhD
Phone 401-455-6200
Email ana_abrantes@brown.edu
Status Recruiting
Phase Phase 4
Start date March 31, 2022
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05176418 - IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate Early Phase 1
Completed NCT04084210 - Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use Phase 2
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Withdrawn NCT03707600 - State and Trait Mediated Response to TMS in Substance Use Disorder N/A
Recruiting NCT03999099 - Targeting Orexin to Treat Nicotine Dependence Phase 1
Completed NCT03847155 - Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery N/A
Completed NCT02840435 - Study on Sit to Quit Phone Intervention N/A
Completed NCT02139930 - Project 2: Strategies for Reducing Nicotine Content in Cigarettes N/A
Completed NCT01926626 - Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers Phase 2
Completed NCT01982110 - A Mindfulness Based Application for Smoking Cessation N/A
Completed NCT01632189 - The Effect of Varenicline on D2/D3 Receptor Binding in Smokers N/A
Withdrawn NCT01569477 - Striving to Quit-Wisconsin Tobacco Quit Line N/A
Completed NCT01569490 - Striving to Quit: First Breath N/A
Completed NCT01685996 - Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation Phase 1/Phase 2
Active, not recruiting NCT01182766 - New Treatment for Alcohol and Nicotine Dependence Phase 2/Phase 3
Completed NCT00996034 - Nicotine Vaccination and Nicotinic Receptor Occupancy Phase 2
Completed NCT01061528 - Coping Skills Treatment for Smoking Cessation N/A
Withdrawn NCT01589081 - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect N/A
Completed NCT01943994 - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study N/A
Suspended NCT01636336 - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects N/A