Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Brown University
Summary
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
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 acce…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 day…
Interventions
- OtherElectronic 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.
- OtherNicotine 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.
Location
- Brown UniversityProvidence, Rhode Island