Clinical trial NCT06948058: Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Official title: Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Obesity and Obesity-related Medical Conditions
Keywords: obesity
electronic cigarettes
harm reduction
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2025-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 3-group design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of cigarettes per day
timeFrame: 2 months
measure: carbon monoxide (CO)
timeFrame: 2 months
measure: number of quit attempts
timeFrame: 2 months
Secondary outcomes:
measure: product acceptability
timeFrame: 2 months
measure: product adherence
timeFrame: 2 months
measure: change in weight
timeFrame: 2 months
measure: change in waist circumference
timeFrame: 2 months
measure: A1c
timeFrame: 2 months
measure: interleukin-6 (IL-6)
timeFrame: 2 months
measure: cotinine
timeFrame: 2 months
measure: diastolic blood pressure
timeFrame: 2 months
measure: systolic blood pressure
timeFrame: 2 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References: