Actively Recruiting
Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Led by Brown University · Updated on 2026-05-18
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study the effects of alternative nicotine products on smoking habits, weight gain, and related health outcomes in individuals who smoke cigarettes and have obesity. The study focuses on comparing electronic cigarettes (EC), nicotine replacement therapy (NRT), and no product use among adults with these health conditions. Up to 60 participants will be involved to provide preliminary information on these interventions. Participants will be randomly assigned to one of three groups: those who receive electronic cigarettes, those who receive nicotine replacement therapy combining transdermal and oral products, and those in a control group who do not receive any alternative nicotine products. Each participant will use their assigned intervention for 8 weeks. The electronic cigarettes and nicotine replacement therapies are provided with information about their risks compared to smoking. Participants will be assessed at the beginning of the study and then at 1, 2, and 3 months after starting. Researchers will measure smoking behavior, exhaled carbon monoxide levels, and the number of quit attempts at 2 months. They will also track product acceptability and adherence, weight changes, waist size, blood sugar control (A1c), inflammation markers, nicotine exposure (cotinine), and blood pressure. Monitoring will include remote measurements via a Bluetooth-enabled device to track carbon monoxide and other outcomes during the study period.
CONDITIONS
Brief Title
Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) 30 kg/m2 or higher (obese)
- Smoked 5 or more cigarettes per day during the past year
- Age 21 years or older
- Exhaled breath carbon monoxide level greater than 6 ppm at baseline to confirm smoking
- Willing to use electronic cigarettes or nicotine replacement therapy for 8 weeks
- Access to a Bluetooth-enabled smartphone or tablet to allow remote monitoring
You will not qualify if you...
- Received any smoking cessation treatment in the past 30 days
- Currently using electronic cigarettes or nicotine replacement therapy more than 2 days per week
- Hospitalized for mental illness in the past 30 days
- Had a heart-related event (e.g., heart attack, severe angina) in the past 30 days
- Living with another person currently enrolled in the study
- Pregnant, nursing, or planning to become pregnant in the next 6 months
- Medical contraindications for study or product use, such as allergies to adhesives
- Taken prescription weight loss medication in the last 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants will switch to electronic cigarettes, nicotine replacement therapy, or receive no alternate nicotine product for 8 weeks.
1 baseline visit and 3 follow-up visits at 1, 2, and 3 months
Trial Site Locations
Total: 1 location
1
Brown University
Providence, Rhode Island, United States, 02912
Actively Recruiting
Research Team
C
CRESCENT Study Research Staff
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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