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

Brown University60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Smoking Cessation Obesity and Obesity-related Medical Conditions

Interventions

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Brown University

Providence, Rhode Island, United States

RECRUITING

Outcomes

Primary Outcomes

number of cigarettes per day

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

Time frame: 2 months

carbon monoxide (CO)

Exhaled breath sample used to measure carbon monoxide

Time frame: 2 months

number of quit attempts

Number of attempts to quit smoking during the experimental period

Time frame: 2 months

Secondary Outcomes

product acceptability

Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable)

Time frame: 2 months

product adherence

Percentage of days using the alternative nicotine product assigned (if applicable)

Time frame: 2 months

change in weight

change in body weight (lbs) from baseline to 2 months

Time frame: 2 months

change in waist circumference

change in waist circumference, a measure of central adiposity, from baseline to 2 months

Time frame: 2 months

A1c

level of A1c, measured via blood sample, as a measure of glucose regulation

Time frame: 2 months

interleukin-6 (IL-6)

Central Contacts

CRESCENT Study Research Staff

CONTACT

401-203-5339 CRESCENT@brown.edu

Data from ClinicalTrials.gov

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