Medical Cannabis Registry and Pharmacology (Med Can Autism)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03699527|
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
|Condition or disease||Intervention/treatment|
|Autism ASD||Behavioral: Multiple questionnaires administered|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Medical Cannabis Registry and Pharmacology|
|Actual Study Start Date :||July 15, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
- Behavioral: Multiple questionnaires administered
This is an observational trial
- Number of children with ASD who use medical cannabis [ Time Frame: 5 years ]The primary objective is to create a registry that will describe the natural history and landscape of medical cannabis and CBD use in the pediatric ASD population.
- Maximum Cannabinoid concentrations in pediatric patients with ASD [ Time Frame: 5 years ]The PK profile of select medical cannabis products in pediatric patients with ASD will be assessed. PK sampling may be performed in the home or at a CHOP site. All Subjects will undergo PK sampling at predetermined times for the determination of cannabinoid concentrations based on the formulation that is being consumed (e.g. If a subject is taking only CBD, Tetrahydrocannabinol (THC) concentrations will not be measured). PK samples will be obtained either using a micro-sampling approach (home or CHOP) or from an indwelling catheter (CHOP site
- Number of families who complete the educational program to assess epidemiologic outcomes [ Time Frame: 5 years ]Families will be informed of epidemiologic outcomes through an educational program for families that have participated in the research for those families who opt for this component. Although these are not research in nature, they are a direct result of the proposed research and are included in the protocol to demonstrate the study's deliverables.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699527
|Contact: Mary Ann DiLiberto, BS, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Mary Ann DiLiberto, BS, RN 267-426-5753 email@example.com|
|Contact: Athena Zuppa, MD, MSCE 2674267359 firstname.lastname@example.org|
|Principal Investigator:||Athena Zuppa, MD, MSCE||Children's Hospital of Philadelphia|