CompletedPhase 2ACTRN12620000941965

The effect of cannabidiol (CBD) on exercise physiology and bioenergetics

A randomised, double-blind, placebo-controlled crossover phase IIa pilot trial exploring the effect of purified oral cannabidiol (CBD) on exercise physiology and bioenergetics in healthy, endurance-trained individuals

Sponsor

University of Sydney

Enrollment

10 participants

Start Date

Aug 31, 2020

Study Type

Interventional

Conditions

Metabolic Disorders

Summary

This study is a randomised, crossover, double-blinded, single-dose experimental trial investigating the effects of purified, oral cannabidiol (CBD) on exercise physiology and bioenergetics in healthy individuals. Participants will complete two experimental sessions involving either (1) CBD (300mg) or (2) Placebo (0mg). Trials will be conducted at the Charles Perkins Centre Research. We hypothesise CBD will decrease submaximal oxygen consumption during moderate intensity exercise (~75% HRmax).

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria4

a) greater than or equal to 18 and less than or equal to 45 years of age;
(b) Endurance-trained individuals; i.e. who have run an average of greater than or equal to 40 km·wk-1 for the last month (or more) and can sustain moderate intensity running exercise for >60-minutes;
(c) No reported use of cannabis or cannabinoids within the past 3 months; to be confirmed by a negative urine drug screen (UDS) at the medical screening; and
(d) Proficient in English (i.e. must not require an English translator).

Exclusion Criteria13

(a) Cannabis dependence or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision (ICD)-10 criteria or at a medical doctor’s discretion;
(b) A history (self-reported) of allergic reaction (e.g. rhinitis, urticaria, contact dermatitis, anaphylaxis) to cannabis, cannabis products or cannabinoids;
(c) A history (self-reported) of a clinically significant adverse response to cannabidiol (CBD);
(d) A history of a major psychiatric disorder within the previous 12 months, as per the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria or at the medical doctor’s discretion, except, mild to moderate depression (score <20 on the Beck Depression Inventory [BDI] or mild to moderate anxiety (score <16 on the Beck Anxiety Inventory [BAI];
(e) A history of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire (PHQ)-9;
(f) A (self-reported) history of, or current, cardiovascular, respiratory, renal, neurological, gastrointestinal, or endocrinological disorders;
(g) A major illness or injury that interrupted their usual training routine for a period of greater than or equal to 3 weeks during the past 3 months;
(h) Inability to refrain from consuming alcohol (24 h) and caffeine (12 h) prior to each experimental trial;
(i) Inability to refrain from using anti-inflammatory medications (24 h) prior to each experimental trial;
(j) Inability to refrain from using other central nervous system active drugs (e.g. cannabis, opioids, benzodiazepines) while participating in this project;
(k) Use of medications that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system);
(l) Use of medications handled by transporter proteins or CYP enzymes that are inhibited by CBD, such as anticoagulants, calcium channel blockers, beta blockers, sulfonylureas and anti-convulsants; and
(m) Required to complete mandatory drug testing for cannabis (e.g. workplace testing, anti-doping in sport testing).

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Interventions

Oral Cannabidiol in Medium Chain Triglyceride Oil (Schedule 4 Drug); 300 mg (single dose) All trials will be separated by a washout period of at least 7 days. As this is an ‘acute dosing’ trial

Oral Cannabidiol in Medium Chain Triglyceride Oil (Schedule 4 Drug); 300 mg (single dose) All trials will be separated by a washout period of at least 7 days. As this is an ‘acute dosing’ trial (i.e. using a single dose of CBD per research session); compliance does not need to be monitored.