Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
- Conditions
- Smoking CessationObesity and Obesity-related Medical Conditions
- Registration Number
- NCT06948058
- Lead Sponsor
- Brown University
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method number of cigarettes per day 2 months Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.
carbon monoxide (CO) 2 months Exhaled breath sample used to measure carbon monoxide
number of quit attempts 2 months Number of attempts to quit smoking during the experimental period
- Secondary Outcome Measures
Name Time Method product acceptability 2 months Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable)
product adherence 2 months Percentage of days using the alternative nicotine product assigned (if applicable)
change in weight 2 months change in body weight (lbs) from baseline to 2 months
change in waist circumference 2 months change in waist circumference, a measure of central adiposity, from baseline to 2 months
A1c 2 months level of A1c, measured via blood sample, as a measure of glucose regulation
interleukin-6 (IL-6) 2 months level of IL-6, measured via blood sample, as a measure of inflammation
cotinine 2 months level of cotinine, measured via blood sample, as a measure of nicotine exposure
diastolic blood pressure 2 months diastolic blood pressure measured using a cuff
systolic blood pressure 2 months systolic blood pressure measured using a cuff
Trial Locations
- Locations (1)
Brown University
🇺🇸Providence, Rhode Island, United States