Influence of Edible Marijuana on Endurance Exercise Performance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Edible Marijuana on Endurance Exercise Performance

Conditions
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Endurance Exercise

Intervention / Treatment
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* Drug: THC 5
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. | Drug: Placebo<br>* Commercially available non-THC fruit snack<br>* Other names: Welch Fruit Snack;|
| Active Comparator: 10 mg THC<br>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<br>* 5 milligrams of THC in gummy form<br>* Other names: Ripple Blood Orange Gummies (Stillwater Brands, Commerce City, CO).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Blood Lactate Levels during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. | Blood will be collected to determine Blood Lactate Levels during standard exercise following ingestion of placebo or active formula. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions | 
| Comparison of Heart Rate during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. | Heart rate will be collected during standard exercise graded exercise following ingestion of placebo or active formula. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions | 
| Comparison of Rating of Perceived Exertion (RPE) during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. | 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. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions | 
| Comparison of Indirect Calorimetry (VO2) during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo. | VO2 will be collected during graded standard exercise following ingestion of placebo or active formula. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions | 
| Comparison of Maximal Mean Power Output to placebo | Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions | 
| Comparison of Time to Exhaustion to placebo | Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions |