Influence of Edible Marijuana on Endurance Exercise Performance

NCT05192239 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 2827
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Endurance Exercise

Outcome Measures

Primary Outcomes (6)

• Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.

  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.

  Blood was collected at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts), and 24 minutes (150 watts) for analysis of blood lactate.

• Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.

  Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.Heart rate will be collected during standard graded exercise following ingestion of placebo or active formula (10mg THC in the form of two 5mg gummies).

  Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts)

• Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.

  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.

  RPE was reported and averaged for each intensity stage at timepoints 0 minutes- 4 minutes (0 watts), 8 minutes-12 minutes (50 watts), 16 minutes-20 minutes (100 watts), and 24 minutes (150 watts).

• Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.

  Separated by a minimum of a 4 day washout period between randomized crossover coded interventionsVO2 will be collected during graded standard exercise following ingestion of placebo or active formula. Expired gasses were measured and averaged during three time points, 5-8 minutes, 13-16 minutes, and 21-24 minutes. Gasses were not collected or recorded outside of those timeframes.

  Expired gasses were measured and averaged during three time points, 5-8 minutes (50 Watts), 13-16 minutes (150 Watts), and 21-24 minutes (150 Watts).

• 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 during high intensity exercise

  Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

10 mg THC

ACTIVE COMPARATOR

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

Interventions

THC 5 DRUG

5 milligrams of THC in gummy form

Also known as: Ripple Blood Orange Gummies (Stillwater Brands, Commerce City, CO).

10 mg THC

Placebo DRUG

Commercially available non-THC fruit snack

Also known as: Welch Fruit Snack

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Bell: lead

Study Sites (1)

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

Location

Related Links

• Link to Published Manuscript

MeSH Terms

Interventions

THC 5

Results Point of Contact

• Title: Christopher Bell, Associate Professor
• Organization: Colorado State University

christopher.bell@colostate.edu

(970) 491-7522

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Coded envelope.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 14, 2022
• Study Start: December 9, 2021
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: April 22, 2024
• Results First Posted: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)