None listed
Conditions
Brief summary
We hypothesise that THC will influence anxiety, autism and psychosis proneness relative to both before drug and to CBD, and that these effects will correlate with THC levels in blood but not saliva or urine. This will be tested by administering THC or CBD to healthy volunteers once only.
Interventions
Each participant will be administered one dose of one drug on one day only, either Delta-9-tetrahydrocannabinol (THC, 5 mg, perioral, once, in a capsule with an olive oil incipient) or Cannabidiol (CBD, 500 mg, perioral, once., in a capsule with an olive oil incipient), while under observation, prescribing by a psychiatrist with Medicinal Cannabis Product Prescribing Authorisation. Blood, urine and saliva samples will be taken for analysis of levels of the drugs and their primary metabolite(s).
Each participant will be administered one dose of one drug on one day only, either Delta-9-tetrahydrocannabinol (THC, 5 mg, perioral, once, in a capsule with an olive oil incipient) or Cannabidiol (CBD, 500 mg, perioral, once., in a capsule with an olive oil incipient), while under observation, prescribing by a psychiatrist with Medicinal Cannabis Product Prescribing Authorisation. Blood, urine and saliva samples will be taken for analysis of levels of the drugs and their primary metabolite(s). Several personality and psychosis-proneness measures will be taken before and after treatment. Blood will be taken just before drug treatment, and then one hour every hour after for 5 hours (total 6 collections). Saliva and urine samples will be taken twice: once before drug treatment and once 2 hours after drug treatment. Personality and psychosis proneness tests will be done twice, just after each saliva/urine collection.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy unmedicated people (with the exceptions of acne and contraceptive medications)
Exclusion criteria
pregnant or breast-feeding; fertile, sexually active and not using contraceptives; ingesting caffeine or any other stimulants on the day of each testing session; using current prescription medications other than oral contraceptives or acne medication; using over-the-counter medications or “natural” therapies in the 48 hours before each testing session; using "recreational drugs" including alcohol in the 48 hours before each testing session; Any medical condition, including mental illness, requiring treatment other than acne; a history of substance abuse disorder; a family history in first degree relatives of any psychotic disorder (e.g., schizophrenia, bipolar disorder, schizoaffective disorder); a history of sensitivity to cannabis (e.g., nausea, dizziness, anxiety).
Outcome results
None listed