Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06948058

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionSmoking Cessation, Obesity and Obesity-related Medical Conditions

Full registry 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

Treatments and study arms

Electronic Cigarettes (EC)

Other

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)

Other

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 outcomes

number of cigarettes per day2 months

Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.

carbon monoxide (CO)2 months

Exhaled breath sample used to measure carbon monoxide

number of quit attempts2 months

Number of attempts to quit smoking during the experimental period

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brown University🇺🇸 Providence, Rhode Island, United States
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