AutismMed Can AutismNCT03699527
Medical Cannabis Registry and Pharmacology
An observational study of Autism and ASD, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 years
- What is being tested?
- Multiple questionnaires administered
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 15 Jan 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Those diagnosed with autism who are under age 21.
Who may be able to join
- Individuals who consume cannabis products in a state which has legalized medical cannabis for the treatment of ASD related symptoms
- Individuals who have a diagnosis of autism spectrum disorder
Who cannot join
- Consumption of cannabis products that are not obtained legally
- Non English speaking individuals
- Greater than 21 years of age for entry into Part 2 of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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 12 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 formulations will begin subjects are enrolled into the Registry and have consented to PK sampling. . 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.
- Being tested
- Multiple questionnaires administered
- Keywords
- medical cannabis
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple questionnaires administeredBehavioural
This is an observational trial
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with ASD who use medical cannabis
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.
Measured: 5 years
Maximum Cannabinoid concentrations in pediatric patients with ASD
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
Measured: 5 years
Secondary outcomes (1)
Number of families who complete the educational program to assess epidemiologic outcomes
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Jul 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Zelda Therapeutics
- Responsible party
- Sponsor
- Investigators
- Athena Zuppa, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699527
- Sponsor's protocol ID
- 17-014628
- Acronym
- Med Can Autism
- Status last verified
- Jan 2020
- First submitted
- 12 Sep 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Cannabis Registry and Pharmacology
- ClinicalTrials.gov ID
- NCT03699527
- Acronym / sponsor ID
- Med Can Autism / 17-014628
- Keywords
- medical cannabis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Zelda Therapeutics
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 12 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 formulations will begin subjects are enrolled into the Registry and have consented to PK sampling. . 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Those diagnosed with autism who are under age 21.
Key inclusion criteria (2 listed)
- Individuals who consume cannabis products in a state which has legalized medical cannabis for the treatment of ASD related symptoms
- Individuals who have a diagnosis of autism spectrum disorder
Key exclusion criteria (3 listed)
- Consumption of cannabis products that are not obtained legally
- Non English speaking individuals
- Greater than 21 years of age for entry into Part 2 of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple questionnaires administeredThis is an observational trial | Behavioural | – |
Primary outcome
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
1 secondary outcome
Number of families who complete the educational program to assess epidemiologic outcomes
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athena Zuppa, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and ASD, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children with ASD who use medical cannabis (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.