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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM130414 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Cigarette (EC) Condition | Experimental | Participants in this condition will receive the EC intervention. |
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| Nicotine Replacement Therapy Condition | Experimental | Participants in this condition will receive the NRT intervention. |
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| No-Product Control Condition (CON) | No Intervention | Participants in this condition will not receive any alternate nicotine product. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CRESCENT Study Research Staff | Contact | 401-203-5339 | CRESCENT@brown.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Recruiting | Providence | Rhode Island | 02912 | United States |
Deidentified data will be kept and used for future research on chronic disease and substance use.
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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.
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.
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D009765 | Obesity |
| D000072137 | Vaping |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004358 | Drug Therapy |
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A 3-group design.
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Outcome assessor will not know the outcome of randomized assignment.
| 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. |
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| 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 |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012907 | Smoking |
| D013812 | Therapeutics |