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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04219189
Other study ID # HM20018382
Secondary ID 2019-066-PBRCU54
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2021
Est. completion date September 21, 2022

Study information

Verified date November 2023
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assesses the acute effects of a standardized 20-minute vaping episode compared to a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal, occurring approximately 45 minutes after the vaping episode


Description:

Weight control is a common motive for cigarette smoking and nicotine has been shown to suppress appetite and increase resting metabolic rate, and also serves as a behavioral alternative to eating or a distraction from hunger or food craving. Data on the acute effect of e-cigarette use ('vaping') on ad libitum food intake are non-existent. Given that many e-cigarette users report vaping for weight control and that certain e-cigarettes are being actively marketed for weight management and/or suppression of food cravings, addressing this research gap is of the utmost importance.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 21, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18 - 65 years of age (ID card verified) - Reports either everyday e-cigarette use with liquid containing at least 0.3% (~3 mg/ml) nicotine or some day e-cigarette use ( at least 3 days a week) with liquid containing at least 3% (~30 mg/ml) nicotine for the past 30 days. Exclusion Criteria: - being unwilling to consume the foods provided due to: a) dietary limitations or preferences or b) allergies to the foods provided. - being unwilling to take 20 puffs from a JUUL device containing a 5% nicotine pod - self-reported current, diagnosed medical condition(s) will be excluded automatically: heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures - observed high blood pressure at screening (systolic >140; diastolic >90) - other self-reported current, diagnosed medical conditions (e.g., specific food allergies, diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor - self-reported current, diagnosed psychiatric conditions or who report current psychiatric treatment or psychotropic medication use - past month use of cocaine, opioids, benzodiazepines, methamphetamine, or other (non-cannabis) illicit drugs - self-report of >25 days out of the past 30 for alcohol use or >20 days out of the past 30 for cannabis use. - women who are breast-feeding or test positive for pregnancy (by urinalysis at screening) - women using progestin-IUDS for birth control - women using birth control injections (e.g., Depo-Provera) - women who received a hysterectomy and still have ovaries present - self-report intending to quit tobacco/nicotine products in the next 30 days

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vaping condition
Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with ~5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.
Control condition
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.

Locations

Country Name City State
United States Center for the Study of Tobacco Products Richmond Virginia

Sponsors (3)

Lead Sponsor Collaborator
Virginia Commonwealth University National Institute on Drug Abuse (NIDA), Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Energy Intake Energy intake in kilocalories (kcal) during the ad libitum buffet meal will be measured via directly weighed food provision and waste (food/energy intake is calculated by difference). intake was assessed over a 30 minute meal
Secondary Dietary Added Sugar Intake Dietary added sugar intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Sugar Intake Dietary sugar intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Fat Intake Dietary fat intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Carbohydrate Intake Dietary carbohydrate intake intake was assessed over a 30 minute meal
Secondary Dietary Protein Intake Dietary protein intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Calcium Intake Dietary calcium intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Cholesterol Intake Dietary cholesterol intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Fiber Intake Dietary fiber intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Iron Intake Dietary iron intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Potassium Intake Dietary potassium intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Sodium Intake Dietary sodium intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Saturated Fat Intake Dietary saturated fat intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Dietary Vitamin D Intake Dietary Vitamin D Intake was calculated across all food consumed during the ad lib buffet meal and summed to estimate total intake and compare between active and control conditions. intake was assessed over a 30 minute meal
Secondary Difference in Food Cravings Total score in the Food Cravings Questionnaire State (FCQ-State) after the vaping vs after the non-vaping condition. Fifteen items are rated on a 5-point Likert Scale (Strongly Disagree=1, Disagree=2, Neutral=3, Agree=4, Strongly Agree=5) with higher scores indicating higher food cravings. For a total score, all 15 items were summed together and higher scores indicate a higher intensity or craving to eat (Meule, 2020). The range for total scores is around 15-75. The FCQ-State was administered about 30 minutes after either the vaping or non-vaping (control) condition and about ~20 minutes before the ad lib buffet meal.
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