Psilocybin in Autism Spectrum Disorder ("PSILAUT")
Overview
Modulation of serotonin pathways using psilocybin in adults with and without autism spectrum disorder
We are recruiting healthy participants (18+) with and without an Autism Spectrum Disorder. Each participant is asked to visit the Denmark Hill campus of KCL on two separate occasions. On each visit, the participant will be asked to take a single dose of one of two single doses of psilocybin or placebo and we will do an MRI brain scan, record EEG and do a cognitive battery of tasks. With this research we are looking at the neurochemical balance in the brain, and how this balance can be shifted by administering a pharmacological agent. This study compensates 120 pounds for participation and additional travel & lunch expenses will be reimbursed.
Are you interested in taking part in this study?
Planned end date
01 Sep 2024 10:04Conditions
Autism Spectrum DisorderInclusion Criteria
For all participants
1. Calendar age above 18 years.
2. Able to give informed consent.
3. Not pregnant or breastfeeding.
4. Ideally prescription medication free during the 2-week period preceding a study visit. However, occasional use of over-the-counter medication (e.g. painkillers) on an as needed basis (and not on the day of study visit) may be permitted. In addition, regular prescription medication (use of a stable dose over the two months preceding participation) with a drug that does not affect 5HT directly may be permitted. Also permitted is topical medication without systemic exposure.
For individuals with ASD
Diagnosis of ASD by recognised clinical service supported by the Autism Diagnostic Interview-Revised (ADI-R) if a relative is available. Current symptom level assessed using the Autism Diagnostic Observation Schedule (ADOS-2).
Exclusion Criteria
For all participants
1. History of allergy/idiosyncrasy to psilocybin or chemically related compounds or excipients which may be employed in the study or to any other drug used in the past
3. Clinically relevant history or presence of any medical disorder, potentially interfering with this study
4. Clinically relevant abnormality at screening as judged by the investigator.
5. History of or current abuse of drugs (including prescription medication) or alcohol or solvents
6. Participation in a research study involving a pharmacological probe or drug trial within last month
7. Subjects with current epilepsy, seizures or episodes of unexplained and unprovoked loss of consciousness
8. Anyone with a history or examination which indicates laboratory testing is needed will be excluded from the study
9. Intelligence Quotient below 70
10. Currently taking prescription medications of propranolol or pindolol.
Reproductive safety Pregnancy or breastfeeding (is a routine exclusion for research MRI scanning). Female study participants must be willing to use one form of highly effective non-hormonal contraception for one week after study drug administration. This would include a vasectomised partner (sole partner), tubal occlusion, intrauterine system [IUS]/hormonal coil or copper containing intrauterine device or copper containing IUD, or true abstinence (when this is in line with the preferred and usual lifestyle of the subject). Women should have been stable on their chosen method of birth control before entering the study. Participants must agree to undergo a pregnancy test prior to each administration of study drug.
For individuals with ASD:
ASD caused by a known genetic syndrome, e.g. Fragile X, 22q11 deletion syndrome.
Currently treated for epilepsy.
