Medical Cannabis Registry and Pharmacology

Part 1 of the study will consist of building a patient registry. Eligible patients will be
identified and consented for study participation.Parents/legal guardians will be asked the
survey related questions from Social Communication Questionnaire (SCQ), personality structure
questionnaire (PSQ), Assessment Battery for Children (ABC2), Behavior Rating Inventory of
Executive Function (BRIEF2), and the Screen for Child Anxiety Related Disorders (SCARED)
(parent version) if appropriate and ASHD5 Rating for either 5-10 year old or 11-17 year old.
The description of each survey is below with a link to more information to the ASHD5. All
additional questionnaires are already validated by the Institutional Review Board (IRB).

Registry information (as detailed below) will be gathered and entered into the registry.Each
subject will be re-contacted approximately every 4-8 weeks to ask whether medications
(cannabis related or other) have changed, efficacy/side effects have changed, or there have
been changes in care or medical history. These new data will be recorded in the registry.
Subjects may continue in the study for the duration of medical cannabis use, until they
remove themselves from the study, or the study closes. All data will remain coded with a
Master log of Subject identification numbers (IDs).

Part 2 of the study consists of pharmacokinetic (PK) evaluation of select subjects.

PK sampling of a select formulation will begin once 10 subjects who are consuming the same
product formulation are enrolled into the Registry and have consented to PK sampling. Ongoing
PK evaluation of additional products will occur once an additional 10 consenting subjects who
are consuming the same formulation are enrolled in Part 1 for a maximum of 20 subjects per
formulation. Subjects will have the opportunity to opt in or out of Part 2 upon the initial
informed consent process for Part 1.

Part 3 of study related activities will include analysis and summary of the data on
approximately a six month basis.

The investigative team will provide study participants with coded summary statistics of
medical cannabis products use in the region (either through email, postal mail). This will
also be presented at a community-based meeting that all study participants are invited to
attend. The study team recognized that participation in a community event will result in loss
of de-identification, but also feel that this will occur on a voluntary basis for all study
participants.

The study team hypothesizes that the community educational programs will provide study
participants an opportunity to connect with others in the community, share concerns, learn
from others and allow the development of community-based support systems.

Inclusion Criteria

1. Individuals who consume cannabis products in a state which has legalized medical
cannabis for the treatment of ASD related symptoms

2. Individuals who have a diagnosis of autism spectrum disorder

Exclusion Criteria

1. Consumption of cannabis products that are not obtained legally

2. Non English speaking individuals

3. Greater than 21 years of age for entry into Part 2 of the study