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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Other: Electronic Cigarettes (EC); Other: Nicotine replacement therapy (NRT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CRESCENT Study Research Staff; Phone Number: 401-203-5339; Email: CRESCENT@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Brown University
      • Contact: CRESCENT Research Staff; Phone Number: 401-203-5339; Email: CRESCENT@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic Cigarette (EC) Condition; Participants in this condition will receive the EC intervention.	Other: 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.
Experimental: Nicotine Replacement Therapy Condition; Participants in this condition will receive the NRT intervention.	Other: 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.
No Intervention: No-Product Control Condition (CON); Participants in this condition will not receive any alternate nicotine product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of cigarettes per day	Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.	2 months
carbon monoxide (CO)	Exhaled breath sample used to measure carbon monoxide	2 months
number of quit attempts	Number of attempts to quit smoking during the experimental period	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
product acceptability	Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable)	2 months
product adherence	Percentage of days using the alternative nicotine product assigned (if applicable)	2 months
change in weight	change in body weight (lbs) from baseline to 2 months	2 months
change in waist circumference	change in waist circumference, a measure of central adiposity, from baseline to 2 months	2 months
A1c	level of A1c, measured via blood sample, as a measure of glucose regulation	2 months
interleukin-6 (IL-6)	level of IL-6, measured via blood sample, as a measure of inflammation	2 months
cotinine	level of cotinine, measured via blood sample, as a measure of nicotine exposure	2 months
diastolic blood pressure	diastolic blood pressure measured using a cuff	2 months
systolic blood pressure	systolic blood pressure measured using a cuff	2 months

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: obesity; harm reduction; electronic cigarettes
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Smoking; Health Behavior; Obesity; Vaping; Smoking Cessation; Harm Reduction; Therapeutics; Drug Therapy; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Electronic Nicotine Delivery Systems; Nicotine Replacement Therapy
• Other Study ID Numbers: STUDY00000326; P20GM130414 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be kept and used for future research on chronic disease and substance use.
• IPD Sharing Time Frame: Clinical Laboratory Core data collected to fulfill the aims of the Center for Addiction and Disease Risk Exacerbation will be available to request immediately following publication, with no prespecified end date.
• IPD Sharing Access Criteria: After all data are collected and the results of the study are published, deidentified data and biospecimens may be made available to other qualified investigators at Brown or other institutions upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No