None listed
Conditions
Brief summary
Cannabidiol (CBD) is a safe non-psychoactive compound in cannabis. It is available with a prescription under the special access scheme. It is available without prescription when approved at dosages less than 150mg. CBD (100mg) in coconut oil (1ml) will be administered to healthy volunteers (n=16) to determine it is present in the blood over time at safe and effective levels. Taking CBD with a fatty meal has been shown to increase blood concentrations. It is not known if taking it with coconut oil will produce a similar effect. The volunteers will receive CBD in coconut oil when fasting and on the second visit after a high-fat breakfast. The CBD (and its metabolites) levels will be monitored via blood collection and LC-MS/MS analysis using a previously validated method. It is expected the CBD levels will approach that of the high-fat group when administered with coconut oil.
Interventions
The intervention is the oral administration of a single dose of cannabidiol (100mg) in coconut oil (1ml). The participants will consume a 'meal effect' breakfast according to FDA guidelines (Food-Effect Bioavailability and Fed Bioequivalence Studies, 2002). This will be approximately 965 calories with 560 calories from fats. The meal will be consumed 30min prior to the dose and the dose followed by 240ml of water. The meal and dose will be supervised by a member of the research team. Participant
The intervention is the oral administration of a single dose of cannabidiol (100mg) in coconut oil (1ml). The participants will consume a 'meal effect' breakfast according to FDA guidelines (Food-Effect Bioavailability and Fed Bioequivalence Studies, 2002). This will be approximately 965 calories with 560 calories from fats. The meal will be consumed 30min prior to the dose and the dose followed by 240ml of water. The meal and dose will be supervised by a member of the research team. Participants will have free access to water excluding 1h prior to and 1h after the dosage. There will be a 6-week washout period before the fed vs fasted cross-over. All participants will complete the fasted condition (comparator) first, followed by the intervention condition (fed) 6 weeks later.
Sponsors
Australian Natural Therapeutics Group (ANTG)
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy individuals with normal cardiovascular, hepatic, and renal function are required because this study is the initial determination of pharmacokinetics. - Aged 18 to 45 years old at the time of consent. - Able and willing to comply with all study procedures. - Willing and able to give informed written consent. - Fluent English speaking.
Exclusion criteria
- Tobacco smoker, current or former. - Binge drinker, current or former (defined as more than 4 standard drinks in a single session OR more than 10 standard drinks in a week. - Takes ANY prescription medication, especially blood thinners/anti-thrombotic agents, anti-inflammatory drugs, hypoglycemics, H2 blockers, proton pump inhibitors, and immunosuppressants. - Frequent use (more than twice weekly) of any non-prescription NSAIDs (including ibuprofen and diclofenac). - Diagnosis of metastatic cancer and in active treatment (including chemo/radio/hormonal/immunotherapy) or with recurrence on last follow-up with oncologist. - Pregnant, breastfeeding, plan to conceive within 6 months (both women and men) or unwillingness to use oral contraceptives. - History of psychiatric disorders (including suicide attempt, schizophrenia, severe depression or anxiety, personality disorder, or history of psychosis). - History of cognitive impairment, seizures, or epilepsy. - History of gastric, small bowel or colonic surgery. - History of liver or renal disease, hyperacidity, gastric/duodenal ulcers, gallbladder problems, or hyperglycaemic, haemophiliac diseases. - History of Type 1 or 2 diabetes, impaired glucose tolerance or with fasting blood sugar level <5.5 mmol/L. - History of substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco). - Had taken cannabinoids for a cannabinoid-based medicine within 6 months prior to the study, or provided a blood sample that tests positive for cannabinoids at the initial timepoint before administration. - Severe unstable heart disease (unstable angina or ischaemic heart disease, heart failure >NYHA Grade 2; uncontrolled hypertension/hypotension); - Allergies to MCT oil (as derived from coconut oil) or cannabidiol. - Vegan, vegetarian, or religiously required to abstain from meat and/or dairy products included in the standardised fat-rich fast-food breakfast meal. - Participation in a clinical trial of another chemical entity. - Conditions causing irreversible or blood transfusion dependent anaemia where the volume of blood sampling required for this study is contraindicated in the opinion of the clinician PI. - Currently on a weight loss program, or ketogenic diet unless it had been stable for 4 weeks before the initial assessment visit and throughout the entire trial period - Participants will be excluded if according to the judgment of their physician they might be vulnerable to drug addiction or mental instability. - Not willing to abstain from recreational drug use (excluding caffeine and alcohol that is not recognised as binge drinking) during the study. - Not a student of or employed by a member of the research team
Outcome results
None listed