Clinical trial NCT04219189: The Acute Effect of Vaping on Food Intake
Official title: The Acute Effect of Vaping on Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Intake
Food Intake
E-Cig Use
Appetite
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study consists of a baseline assessment which is followed by two within-subject, laboratory conditions that differ by the product used: 1) JUUL e-cigarette with a 5% nicotine pod, 2) no active e-cigarette use (uncharged JUUL with empty pod). The condition orders (i.e., 1 then 2, or 2 then 1) will be randomly ordered and assigned following enrollment. During the vaping condition, participants will be asked to take 20 e-cigarette puffs over 20 minutes before consuming an ad libitum buffet meal. During the alternative control condition, participants will have access to an uncharged JUUL with an empty pod for 20 minutes (instead of vaping) before consuming an ad libitum buffet meal.
Primary purpose: OTHER

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Energy Intake
timeFrame: intake was assessed over a 30 minute meal
Secondary outcomes:
measure: Dietary Added Sugar Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Sugar Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Fat Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Carbohydrate Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Protein Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Calcium Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Cholesterol Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Fiber Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Iron Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Potassium Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Sodium Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Saturated Fat Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Dietary Vitamin D Intake
timeFrame: intake was assessed over a 30 minute meal
measure: Difference in Food Cravings
timeFrame: 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.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Center for the Study of Tobacco Products
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Caroline Cobb (Amey), PhD
role: PRINCIPAL_INVESTIGATOR
References: