Status:
RECRUITING
Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Smoking Cessation
Obesity and Obesity-related Medical Conditions
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 individ...
Eligibility Criteria
Inclusion
- body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)
- smoked ≥ 5 cigarettes/day during the past year
- 21 or older (due to minimum legal age EC restrictions)
- exhaled breath carbon monoxide (CO) level \> 6 ppm at Baseline (BL) (to confirm self-reported smoking)
- willing to use EC or NRT for 8 weeks
- access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)
Exclusion
- received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking),
- currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products)
- hospitalized for mental illness in past 30 days
- heart-related event (e.g., heart attack, severe angina) in past 30 days
- residing with another person currently enrolled in the study
- pregnant, nursing, or planning to become pregnant in the next 6 months
- medical contraindication for study or product use (e.g., allergy to adhesives)
- taken prescription weight loss medication in the last 30 days
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06948058
Start Date
April 1 2025
End Date
August 31 2027
Last Update
April 29 2025
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 02912