RecruitingNot ApplicableNCT06948058

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


Sponsor

Brown University

Enrollment

60 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 21 Years

Inclusion Criteria6

  • body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)
  • smoked ≥ 5 cigarettes/day during the past year
  • 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 Criteria8

  • 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

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Interventions

OTHERElectronic 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.

OTHERNicotine 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.


Locations(1)

Brown University

Providence, Rhode Island, United States

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NCT06948058


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