An interventional study of Electronic Cigarettes (EC) and Nicotine replacement therapy (NRT) in Smoking Cessation and Obesity and Obesity-related Medical Conditions, sponsored by Brown University. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Brown University · Not applicable, Interventional, and Treatment
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
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.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 60 is below the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this condition will receive the EC intervention.
Other: Electronic Cigarettes (EC)
Participants in this condition will receive the NRT intervention.
Other: Nicotine replacement therapy (NRT)
Participants in this condition will not receive any alternate nicotine product.
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.
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.
number of cigarettes per day
Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.
Time frame: 2 months
carbon monoxide (CO)
Exhaled breath sample used to measure carbon monoxide
Time frame: 2 months
number of quit attempts
Number of attempts to quit smoking during the experimental period
Time frame: 2 months
product acceptability
Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable)
Time frame: 2 months
product adherence
Percentage of days using the alternative nicotine product assigned (if applicable)
Time frame: 2 months
change in weight
change in body weight (lbs) from baseline to 2 months
Time frame: 2 months
change in waist circumference
change in waist circumference, a measure of central adiposity, from baseline to 2 months
Time frame: 2 months
A1c
level of A1c, measured via blood sample, as a measure of glucose regulation
Time frame: 2 months
interleukin-6 (IL-6)
level of IL-6, measured via blood sample, as a measure of inflammation
Time frame: 2 months
cotinine
level of cotinine, measured via blood sample, as a measure of nicotine exposure
Time frame: 2 months
diastolic blood pressure
diastolic blood pressure measured using a cuff
Time frame: 2 months
systolic blood pressure
systolic blood pressure measured using a cuff
Time frame: 2 months
Plan to share: Yes — Deidentified data will be kept and used for future research on chronic disease and substance use.
Time frame: Clinical Laboratory Core data collected to fulfill the aims of the Center for Addiction and Disease Risk Exacerbation will be available to request immediately following publication, with no prespecified end date.
Access criteria: After all data are collected and the results of the study are published, deidentified data and biospecimens may be made available to other qualified investigators at Brown or other institutions upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for May 2027, 25 months after the start.
Of 546 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 25 months is close to that.
Counting every sponsor, half of 563 studies reached it within 24 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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