United States

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United States Department of Defense

PURPOSE:  The purpose of this research study is to find out if a medicine called cannabidivarin (CBDV), which is made from a part of a plant, can help children with ASD to feel better.

STUDY DESIGN:

This study is a two-site 12-week double blind placebo-controlled parallel design study of CBDV. This means that neither the study team, nor your family will know whether your child is on drug or placebo. It will be randomly determined whether he/she receives drug or placebo.

This study requires a screening visit to determine your eligibility for the study. Once you are determined eligible, you will be asked to make 8 visits in total to our program. These visits will occur every two week. At these visits, you and your child will meet with a psychologist to completed several different questionnaires and assessments. In addition, you will meet with our study doctors to complete physical and neuro-cognitive evaluations. At five of these visits, you child will have to provide a small blood sample in order for us to analyze a few safety labs. The medicine used to treat your child in this research study may cause some side effects. These side effects include: feeling dizzy, feeling not feel very hungry, feeling moody and/or feeling tired. There is no cost for being in this research study. Subjects will receive a total of $370 ($50 for screening visit and $40 for the following 8 study visits) for participation in this research study.

We are just beginning to start our recruitment process. Please note that prior use of cannabis will disqualify you from participating in this study.  If you’d like to be on the call list, please provide the following information to Erin Shanahan at  [email protected]:

• Best Phone Number for Contact
• Best Email Address to have on file
• Home Address to have on file
• Parental Guardian’s Name
• Parental Guardian’s Date of Birth
• Potential Patient’s Name
• Potential Patient Age
• Potential Patient’s Date of Birth
• Potential Patient’s Preferred Spoke and Written Language
• Potential Patient’s Race and Ethnicity
• Potential Patient’s Medications and Dose

https://clinicaltrials.gov/ct2/show/NCT03202303

Canada

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Project Title: An Exploration of the Pediatric Family Lived Experience with Cannabis Treatment: Raising Awareness with Health Professionals and Educators.

ABSTRACT

This research study is to elicit, analyze, and interpret the perceptions of parents in the Province of British Columbia, about the unique challenges and opportunities they face while caring for their child with a neurological disorder, who receives cannabis-related intervention. Literature and support for treating neurologic disorders with cannabis-based products in a pediatric population is scarce (Patel, 2016). The majority of the research to date regarding nontraditional medical options, such as cannabis interventions is poorly understood and lacks evidence related to the lived experiences; considering new legislation related to medical uses of cannabis has recently been passed. The qualitative research design uses the multi-case study methodology (Yin, 2017), with a mixed method approach to data collection. The researchers will conduct in-depth interviews with the caregivers, as well a questionnaire using a Likert scale will be utilized for quantitative data. The study will benefit parents considering cannabis-related intervention for their child with neurological disorders, pediatric health care service providers, and leaders of policy and legislative development related to comprehensive pediatric intervention. The findings may assist in creating a clearer understanding of the use of medical cannabis as a pediatric treatment option; and the journeys families endure to obtain access. As well, the findings will inform medical practitioners of the demand for alternate treatment options with regard to neurological disorders, and contribute to the greater conversation focusing on physician education, community awareness and acceptance of medical cannabis as a credible intervention for children

Note: TRU Research Ethics Approval Completed File # File No:101739 

To participate, please email Dr. Florriann Fehr at [email protected] or Dr. Nan Stevens at [email protected]

Coming Soon:

University of California, San Diego