Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy

Last updated: April 22, 2025
Sponsor: Brown University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Smoking Cessation

Diabetes Prevention

Treatment

Electronic Cigarettes (EC)

Nicotine replacement therapy (NRT)

Clinical Study ID

NCT06948058
STUDY00000326
P20GM130414
  • Ages > 21
  • All Genders

Study Summary

This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.

Eligibility Criteria

Inclusion

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 confirmself-reported smoking)

  • willing to use EC or NRT for 8 weeks

  • access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of COand other outcome variables)

Exclusion

Exclusion Criteria:

  • received smoking cessation treatment of any kind in the past 30 days (activelyquitting smoking),

  • currently using EC or NRT more than 2 days/week (this may affect responses tostudy-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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Electronic Cigarettes (EC)
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Brown University

    Providence, Rhode Island 02912
    United States

    Active - Recruiting

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