Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Recruiting · NCT06948058 · Interventional (participants receive a specific treatment) · Lead sponsor: Brown University
View the official record on ClinicalTrials.gov →Interventions studied
Electronic Cigarettes (EC)Nicotine replacement therapy (NRT)
What this trial is about
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- Brown University - Providence, Rhode Island, United States