Influence of Edible Marijuana on Endurance Exercise Performance

NCT ID: NCT05192239

Last Updated: 2024-04-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2022-07-19

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.

Conditions

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Endurance Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Coded envelope.

Study Groups

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Placebo

Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Commercially available non-THC fruit snack

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.

Group Type ACTIVE_COMPARATOR

THC 5

Intervention Type DRUG

5 milligrams of THC in gummy form

Interventions

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THC 5

5 milligrams of THC in gummy form

Intervention Type DRUG

Placebo

Commercially available non-THC fruit snack

Intervention Type DRUG

Other Intervention Names

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Ripple Blood Orange Gummies (Stillwater Brands, Commerce City, CO). Welch Fruit Snack

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christopher Bell

OTHER

Sponsor Role lead

Responsible Party

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Christopher Bell

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/36545283/

Link to Published Manuscript

Other Identifiers

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2827

Identifier Type: -

Identifier Source: org_study_id

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