None listed
Conditions
Brief summary
An open label trial evaluating the feasibility of a medicinal cannabis product for the symptoms associated with adult autism such as anxiety. The participants will complete a 3-week titration then stay on that dose for 12 weeks thereafter. There will be four weekly follow up visits in person and safety bloods will be taken. The trial is assessing if it is feasible to conduct a trial using medicinal cannabis in an adult Autism population. It is assumed that it will be feasible, and that medicinal cannabis will help reduce anxiety and improve quality of life.
Interventions
The medicinal cannabis product (FD-202) has been specifically made for this trial. A combination of cannabidiol (CBD), Cannabigerol (CBG) and tetrahydrocannabinol (THC) with added limonene was selected based on their individual properties.
Dose: 1-1.2 ml per day.
Duration: 84 days
Mode of administration: oral ingestion
Monitoring adherence: Is through self-report, participant diary and measurement of IMP
The start dose of the titration is 0.2ml and this will be increased every 2 days by 0.2m
The medicinal cannabis product (FD-202) has been specifically made for this trial. A combination of cannabidiol (CBD), Cannabigerol (CBG) and tetrahydrocannabinol (THC) with added limonene was selected based on their individual properties. Dose: 1-1.2 ml per day. Duration: 84 days Mode of administration: oral ingestion Monitoring adherence: Is through self-report, participant diary and measurement of IMP The start dose of the titration is 0.2ml and this will be increased every 2 days by 0.2ml. The duration of the up-titration period is three weeks and will be until the participants reach there tolerated dose with a maximum of 1.2ml per day. If participants do not tolerate a dose, they will cease titration at the dose they tolerated and will remain on that dose for the remainder of the study period. The following active ingredients are contained in each milliliter of FD-202. FD-202 is dispensed in a 30 ml brown bottle with a 1ml syringe with 0.1ml graduations at a minimum to allow for accurate dosing: cannabidiol (CBD) 200mg/ml, cannabigerol (CBG) 50mg/ml, THC 5mg/ml, limonene 5mg/ml.
Sponsors
Southern Cross University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Written confirmation of Autism / ASD diagnosis by an APHRA registered Pediatrician, Clinical Psychologist or Psychiatrist - An anxiety score of equal or greater than 7 as per DSM-GAD PROM or a score of equal or greater than 5 and clinically assessed for inclusion in this cohort - Age equal or great than 18 years - Able to give written informed consent as per consenting Investigator’s judgement - Able to complete self-reported questionnaires and the requirements of the trial as per consenting Investigator’s judgement
Exclusion criteria
Medical history - Clinically significant, unstable concurrent disease (as per consenting Investigator) - Known, clinically significant allergy to any element of the cannabis plant - Known, clinically significant allergy to coconut Medication use - Concurrent use of any medication judged to be likely to have a clinically significant interaction with medicinal cannabis - Current chemotherapy, radiation, immune suppressant therapy, or immunotherapy - Use of any cannabis or CBD/CBG/THC/limonene-containing product within the 28 days prior to Screening or during the course of the trial. Pathology abnormalities - Liver enzymes greater than 2 x ULN and of clinical significance - eGFR below normal range for age/gender as per pathology provider, and of clinical significance - Creatinine greater than ULN and of clinical significance Lifestyle - Current recreational drug use, or use during the course of the trial - Current, consistent alcohol intake of greater than 14 standard drinks per week Other exclusion criteria - Pregnancy, breast-feeding or refusal to use highly effective* contraception during the trial - Employee or student of the Principal Investigator - Any participant for whom trial participation would not be in the participant’s best interest or whose data would have questionable validity, as per PI discretion *Highly effective contraception includes established oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), sterilised male partner with confirmation of absence of sperm in the ejaculate and true abstinence (when this is in line with the participants preferred and usual lifestyle)
Outcome results
None listed