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

Phase 2

Recruiting

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

• Registration Number: ACTRN12622000717752
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-19
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

(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 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)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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Affective valence (pleasure-displeasure) on the Feelings Scale during submaximal intensity running exercise (70%VO2max; treadmill).[110- , 130- (primary endpoint), 150-minutes post drug administration]