Evaluating smoking cessation using e-cigarettes and nicotine therapy
Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
This study is testing whether using e-cigarettes or nicotine replacement therapy can help people with obesity who smoke quit smoking and manage their weight better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Brown University Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06948058 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of electronic cigarettes (EC) and nicotine replacement therapy (NRT) on smoking cessation and weight management among individuals with obesity who smoke. The study will randomize up to 60 participants to receive either EC, NRT, or a control condition for 8 weeks. Assessments will be conducted at baseline and follow-ups at 1, 2, and 3 months to compare the effectiveness of these interventions on smoking behavior, weight, and related health outcomes. The study aims to provide preliminary data on the acceptability and adherence to these nicotine products.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with a BMI of 30 or higher who smoke at least 5 cigarettes per day.
Not a fit: Patients who have recently received smoking cessation treatment or are currently using e-cigarettes or nicotine replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective smoking cessation options for individuals with obesity, potentially improving their overall health.
How similar studies have performed: Other studies have shown promise in using alternative nicotine products for smoking cessation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Providence, Rhode Island
- Brown University — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: CRESCENT Study Research Staff
- Email: CRESCENT@brown.edu
- Phone: 401-203-5339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.