Smoking CessationCRESCENTNCT06948058
Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
A study testing Electronic Cigarettes (EC) and Nicotine replacement therapy (NRT) in people with Smoking Cessation and Obesity and Obesity-related Medical Conditions, run by Brown University at 1 site in United States.
Trial summary
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking Cessation, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Electronic Cigarettes (EC) and Nicotine replacement therapy (NRT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown University
Providence, Rhode Island, 02912
CRESCENT Research Staff, 401-203-5339, CRESCENT@brown.edu
About this study
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
Read the 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.
- Being tested
- Electronic Cigarettes (EC), Nicotine replacement therapy (NRT)
- Keywords
- obesity, electronic cigarettes, harm reduction
- Medical subject headings
- Smoking Cessation, Obesity, Vaping, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Cigarette (EC) Condition | Experimental | Participants in this condition will receive the EC intervention. Receives: Other: Electronic Cigarettes (EC) |
| Nicotine Replacement Therapy Condition | Experimental | Participants in this condition will receive the NRT intervention. Receives: Other: Nicotine replacement therapy (NRT) |
| No-Product Control Condition (CON) | No intervention | Participants in this condition will not receive any alternate nicotine product. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cigarettes per day
Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.
Measured: 2 months
carbon monoxide (CO)
Exhaled breath sample used to measure carbon monoxide
Measured: 2 months
number of quit attempts
Number of attempts to quit smoking during the experimental period
Measured: 2 months
Secondary outcomes (9)
product acceptability
Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable)
Measured: 2 months
product adherence
Percentage of days using the alternative nicotine product assigned (if applicable)
Measured: 2 months
change in weight
change in body weight (lbs) from baseline to 2 months
Measured: 2 months
change in waist circumference
change in waist circumference, a measure of central adiposity, from baseline to 2 months
Measured: 2 months
A1c
level of A1c, measured via blood sample, as a measure of glucose regulation
Measured: 2 months
interleukin-6 (IL-6)
level of IL-6, measured via blood sample, as a measure of inflammation
Measured: 2 months
cotinine
level of cotinine, measured via blood sample, as a measure of nicotine exposure
Measured: 2 months
diastolic blood pressure
diastolic blood pressure measured using a cuff
Measured: 2 months
systolic blood pressure
systolic blood pressure measured using a cuff
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Apr 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 3-group design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948058
- Sponsor's protocol ID
- STUDY00000326
- Other IDs
- P20GM130414
- Acronym
- CRESCENT
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be kept and used for future research on chronic disease and substance use.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy
- ClinicalTrials.gov ID
- NCT06948058
- Acronym / sponsor ID
- CRESCENT / STUDY00000326
- Keywords
- obesity, electronic cigarettes, harm reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A 3-group design.
| Arm | Type | Receives |
|---|---|---|
| Electronic Cigarette (EC) Condition | Experimental | Other: Electronic Cigarettes (EC)Participants in this condition will receive the EC intervention. |
| Nicotine Replacement Therapy Condition | Experimental | Other: Nicotine replacement therapy (NRT)Participants in this condition will receive the NRT intervention. |
| No-Product Control Condition (CON) | No intervention | –Participants in this condition will not receive any alternate nicotine product. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Electronic Cigarette (EC) Condition |
| 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. | Other | Nicotine Replacement Therapy Condition |
Primary outcome
number of cigarettes per day
Time frame: 2 months
Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.
carbon monoxide (CO)
Time frame: 2 months
Exhaled breath sample used to measure carbon monoxide
number of quit attempts
Time frame: 2 months
Number of attempts to quit smoking during the experimental period
9 secondary outcomes
product acceptability
Time frame: 2 months
product adherence
Time frame: 2 months
change in weight
Time frame: 2 months
change in waist circumference
Time frame: 2 months
A1c
Time frame: 2 months
interleukin-6 (IL-6)
Time frame: 2 months
cotinine
Time frame: 2 months
diastolic blood pressure
Time frame: 2 months
systolic blood pressure
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be kept and used for future research on chronic disease and substance use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Cigarettes (EC) and Nicotine replacement therapy (NRT) in people with Smoking Cessation and Obesity and Obesity-related Medical Conditions, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CRESCENT Study Research Staff (401-203-5339, CRESCENT@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cigarettes per day (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.