CompletedPhase 2ACTRN12622000717752

The Effects of Cannabidiol (CBD) on Affective and Physiological Responses to Exercise in Healthy Endurance-Trained Runners

The Acute Effects of Cannabidiol on Affective and Physiological Responses to Exercise in Healthy Endurance-Trained Runners: A Randomised, Double-blind, Placebo-controlled, Dose-ranging, Crossover Trial

Sponsor

University of Sydney

Enrollment

25 participants

Start Date

Oct 17, 2022

Study Type

Interventional

Conditions

Metabolic Disorders

Summary

This study is a randomised, double-blind, placebo-controlled, dose-ranging crossover study, investigating the effects of purified, oral cannabidiol (CBD) on affective and physiological responses to aerobic exercise in healthy trained individuals. Participants will attend the study site on four occasions to complete an initial eligibility screen and three treatment sessions. Each treatment session will involve a controlled bout of submaximal exercise (i.e., 60 minutes of running at a fixed, moderate intensity, ~70% VO2max), a short (30 minute) recovery and an incremental run to volitional exhaustion. Individuals will receive placebo or an acute dose of CBD (50mg or 300 mg) 1.5-hours prior to the onset of exercise on each occasion. We hypothesise that CBD will improve overall exercise tolerance; that is, it will increase affective valence, decrease relative VO2 (i.e., % VO2max) during submaximal exercise and increase time to exhaustion (TTE).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria5

(a) Healthy individuals aged between 18–45 years
(b) Endurance-trained runners, i.e., who have run an average of more 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) The use of hormonal contraception for more than (or equal to) 3 months (for females)
(d) 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
(e) Proficient in English and able to provide informed consent

Exclusion Criteria15

(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) Pregnant or lactating. All female volunteers of child-bearing potential will be required to complete a human chorionic gonadotrophin (hCG) urine screen to rule out pregnancy at the medical screening and prior to each treatment session. All females of child-bearing potential and males with female partners must agree to use a reliable form of contraception during and one month following their participation in this project
(h) A major illness or injury that interrupted their usual training routine for a period of more than (or equal to) 3 weeks during the past 3 months;
(i) Inability to refrain from using anti-inflammatory medications (4 days) prior to each treatment session;
(j) Inability to refrain from consuming alcohol (24 h) and caffeine (12 h) prior to each treatment session;
(k) Inability to refrain from using cannabis, cannabinoids and illicit drugs while participating in this project;
(l) Use of medications that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system);
(m) 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
(n) Required to complete mandatory drug testing for cannabis (e.g., workplace testing)
(o) Competing in a World Anti-Doping Agency (WADA) sanctioned sporting event (within 3 months).

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Interventions

Cannabidiol (CBD) in medium chain triglyceride (MCT) oil (100mg/mL); Schedule 4 drug (contains <0.01mg/mL THC). Placebo will be MCT oil only. Treatments will be administered orally. Arm 1: 50mg CBD

Cannabidiol (CBD) in medium chain triglyceride (MCT) oil (100mg/mL); Schedule 4 drug (contains <0.01mg/mL THC). Placebo will be MCT oil only. Treatments will be administered orally. Arm 1: 50mg CBD (single dose); comprised of 0.5mL active oil and 2.5mL placebo oil (3mL total) Arm 2: 300 mg CBD (single dose) comprised of 3mL active oil (3mL total) 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.