We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Influence of Edible Marijuana on Endurance Exercise Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05192239
Recruitment Status : Active, not recruiting
First Posted : January 14, 2022
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Christopher Bell, Colorado State University

Brief Summary:
Lots of people, including athletes and people who like to exercise regularly, enjoy marijuana. Some people believe marijuana might improve their ability to exercise. There are no recent, up-to-date scientific studies to suggest that this belief is right or wrong. The goal of this study is to determine the influence of marijuana on exercise performance.

Condition or disease Intervention/treatment Phase
Endurance Exercise Drug: THC 5 Drug: Placebo Not Applicable

Detailed Description:

The purpose of the proposed project is to provide athletes and the scientific community with data pertaining to the acute influence of edible marijuana on exercise performance, and the physiological responses to standardized exercise. Specifically, the investigators wish to determine: 1. The influence of edible marijuana on cardio-respiratory and metabolic responses to standardized cycle ergometer exercise. 2. The influence of edible marijuana on endurance exercise (time-trial) performance.

The investigators wish to determine if edible marijuana, ingested prior to exercise, is ergogenic (improves performance) or ergolytic (decreases performance).

The investigators hypothesize that edible marijuana will be ergolytic.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
Masking: Double (Participant, Investigator)
Masking Description: Coded envelope.
Primary Purpose: Basic Science
Official Title: Influence of Edible Marijuana on Endurance Exercise Performance
Actual Study Start Date : December 9, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Placebo Comparator: Placebo
Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout.
Drug: Placebo
Commercially available non-THC fruit snack
Other Name: Welch Fruit Snack

Active Comparator: 10 mg THC
Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout.
Drug: THC 5
5 milligrams of THC in gummy form
Other Name: Ripple Blood Orange Gummies (Stillwater Brands, Commerce City, CO).




Primary Outcome Measures :
  1. Comparison of Blood Lactate Levels during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. [ Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions ]
    Blood will be collected to determine Blood Lactate Levels during standard exercise following ingestion of placebo or active formula.

  2. Comparison of Heart Rate during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. [ Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions ]
    Heart rate will be collected during standard exercise graded exercise following ingestion of placebo or active formula.

  3. Comparison of Rating of Perceived Exertion (RPE) during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. [ Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions ]
    During standard exercise, participants will be asked to report Rating of Perceived Exertion (RPE) on a scale from 6-20 (6 is no exertion and 20 is maximal exertion) during a graded standard exercise test following ingestion of placebo or active formula.

  4. Comparison of Indirect Calorimetry (VO2) during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. [ Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions ]
    VO2 will be collected during graded standard exercise following ingestion of placebo or active formula.

  5. Comparison of Maximal Mean Power Output to placebo [ Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions ]
    Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula

  6. Comparison of Time to Exhaustion to placebo [ Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions ]
    Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the age of 21 and 40.
  • Weigh more than 110 pounds
  • Habitual user of cannabis; average use of THC minimum of once per month during the previous year
  • Prior use of cannabis product containing at least 10 mg of THC with no adverse reaction
  • Habitual exerciser: exercised a minimum of 5 days per week, for a minimum of 30-minutes/session, during the previous year.

Exclusion Criteria:

  • Identification of a contra-indication to exercise during a 12-lead exercise stress test.
  • Pregnant or trying to become pregnant. Breastfeeding.
  • Recipient of treatment for psychotic or bipolar disorder during the previous 2 years
  • Recipient of treatment for Schizophrenia during the previous 2 years
  • Planned surgery scheduled within 2-weeks of study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05192239


Locations
Layout table for location information
United States, Colorado
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, United States, 80523-1582
Sponsors and Collaborators
Christopher Bell
Layout table for additonal information
Responsible Party: Christopher Bell, Associate Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT05192239    
Other Study ID Numbers: 2827
First Posted: January 14, 2022    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders