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Medical Cannabis Registry and Pharmacology (Med Can Autism)

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ClinicalTrials.gov Identifier: NCT03699527
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Zelda Therapeutics
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The overall goals of this research is to describe the 1) natural history of current use and disposition of medical cannabis products including Cannabidiol (CBD) products, being administered to children as standard of care for the treatment of Autism Spectrum Disorder (ASD), 2) understand the pharmacokinetic and pharmacodynamics of medical cannabis products and 3) provide educational feedback on what is learned to families and care providers to provide evidenced based dosing guidance for these products to the pediatric community.

Condition or disease Intervention/treatment
Autism ASD Behavioral: Multiple questionnaires administered

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana


Intervention Details:
  • Behavioral: Multiple questionnaires administered
    This is an observational trial


Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those diagnosed with autism who are under age 21.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Mary Ann DiLiberto, BS, RN 2674265753 diliberto@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Ann DiLiberto, BS, RN    267-426-5753    diliberto@email.chop.edu   
Contact: Athena Zuppa, MD, MSCE    2674267359    zuppa@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Zelda Therapeutics
Investigators
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Principal Investigator: Athena Zuppa, MD, MSCE Children's Hospital of Philadelphia

Additional Information:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03699527     History of Changes
Other Study ID Numbers: 17-014628
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Philadelphia:
medical cannabis

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders