Recruiting

E-Cigarettes & Nicotine Therapy

Sponsor:

Brown University

Code:

NCT06948058

Conditions

Smoking Cessation

Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Electronic Cigarettes (EC)

Nicotine replacement therapy (NRT)

Study Details

Brief summary:

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

Conditions

Smoking Cessation

Obesity and Obesity-related Medical Conditions

Study ID

NCT06948058

Start date

Apr 1, 2025

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Electronic Cigarette (EC) Condition

Participants in this condition will receive the EC intervention.

experimental: Nicotine Replacement Therapy Condition

Participants in this condition will receive the NRT intervention.

no intervention: No-Product Control Condition (CON)

Participants in this condition will not receive any alternate nicotine product.

Interventions

Electronic Cigarettes (EC)

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.

Nicotine replacement therapy (NRT)

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.

Primary outcome measure

  • number of cigarettes per day [ Time Frame: 2 months ]
  • carbon monoxide (CO) [ Time Frame: 2 months ]
  • number of quit attempts [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

CRESCENT Study Research Staff

401-203-5339CRESCENT@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

CRESCENT Research Staff

401-203-5339CRESCENT@brown.edu

More Information

Sponsor

Brown University

Last update posted

May 18, 2026

Last verified

Apr, 2026

Keywords

  • obesity
  • electronic cigarettes
  • harm reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2026-05-18.