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

Phase 2

Completed

• Conditions: Metabolic Disorders; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12620000941965
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-21
• Study Completion: 2020-10-23
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

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 Criteria

(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). 

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygen utilisation (VO2) during submaximal intensity exercise (~75%HRmax) while the subject is on a treadmill using a metabolic cart[90-150 min post-drug administration]