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

Brown University

Status: Enrolling

Conditions: Obesity and Obesity-related Medical Conditions; Smoking Cessation

Treatments: Other: Electronic Cigarettes (EC); Other: Nicotine replacement therapy (NRT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06948058

P20GM130414 (U.S. NIH Grant/Contract)

STUDY00000326

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Electronic Cigarette (EC) Condition

Experimental group

Description:

Participants in this condition will receive the EC intervention.

Treatment:

Other: Electronic Cigarettes (EC)

Nicotine Replacement Therapy Condition

Experimental group

Description:

Participants in this condition will receive the NRT intervention.

Treatment:

Other: Nicotine replacement therapy (NRT)

No-Product Control Condition (CON)

No Intervention group

Description:

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