NCT06948058

Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.

Detailed description

The purpose of this study is to provide preliminary information on the effect of electronic cigarettes (EC) and nicotine replacement therapy (NRT) among SWO. This study will randomize up to 60 individuals who smoke cigarettes with comorbid obesity (SWO) to receive (1) electronic cigarettes (EC), (2) nicotine replacement therapy (NRT), or 3) a no-product control (CON) condition for 8 weeks. Assessments will occur at baseline, and 1, 2, and 3-months follow-up, aiming: 1) To compare EC, NRT, and CON on smoking, exhaled carbon monoxide, and number of quit attempts; 2) To compare EC and NRT on acceptability and adherence; 3) To compare EC, NRT, and CON effects on weight, central adiposity, glucose regulation, inflammation, cotinine, and blood pressure at follow-up.

Conditions

• Smoking Cessation
• Obesity and Obesity-related Medical Conditions

Interventions

Type	Name	Description
OTHER	Electronic Cigarettes (EC)	Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to EC for 8 weeks, with EC provided.
OTHER	Nicotine replacement therapy (NRT)	Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to combination NRT (transdermal + oral) for 8 weeks, with NRT provided.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-05-31
• Completion: 2027-08-31
• First posted: 2025-04-29
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States