The Acute Effect of Vaping on Food Intake

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04219189
Collaborator
Pennington Biomedical Research Center (Other), National Institute on Drug Abuse (NIDA) (NIH)
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Vaping condition
  • Other: Control condition
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Acute Effect of Vaping on Food Intake
Actual Study Start Date :
Sep 22, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vaping to Control Group

Participants in this arm will undergo the vaping condition during the first visit and the control condition during the second visit.

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.

Other: Control condition
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.

Experimental: Control to Vaping Group

Participants in this arm will undergo the control condition during the first visit and the vaping condition during the second visit.

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.

Other: Control condition
Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.

Outcome Measures

Primary Outcome Measures

  1. Energy Intake [30 minutes]

    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).

Secondary Outcome Measures

  1. Dietary Fat Intake [30 minutes]

    Dietary fat intake in kilocalories (kcal) during the ad libitum buffet meal will be measured via directly weighed dietary fat provision and waste (dietary fat intake is calculated by difference).

  2. Carbohydrate Intake [30 minutes]

    Carbohydrate intake in kilocalories (kcal) during the ad libitum buffet meal will be measured via directly weighed carbohydrate provision and waste (carbohydrate intake is calculated by difference).

  3. Protein Intake [30 minutes]

    Protein intake in kilocalories (kcal) during the ad libitum buffet meal will be measured via directly weighed protein provision and waste (protein intake is calculated by difference).

  4. Difference in Food Cravings [Visit 1 to visit 2 (1 week)]

    Total score in the Food Cravings Questionnaire 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18 - 65 years of age (ID card verified)

  • Reports using an e-cigarette containing at least 3% (30 mg/ml) nicotine on a frequent basis - defined as at least 3 days per week 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for the Study of Tobacco Products Richmond Virginia United States 23220

Sponsors and Collaborators

  • Virginia Commonwealth University
  • Pennington Biomedical Research Center
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Caroline Cobb (Amey), PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT04219189
Other Study ID Numbers:
  • HM20018382
  • 2019-066-PBRC
  • U54DA036105
First Posted:
Jan 6, 2020
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 11, 2022