Effect of CBD on the Brain

Launched by UNIVERSITÉ DE SHERBROOKE · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a compound called cannabidiol (CBD) on the brain in individuals with Fragile X Syndrome (FXS), a genetic condition that is a leading cause of autism. People with FXS often experience challenges like anxiety and aggressive behaviors, and researchers believe that CBD might help improve these symptoms by affecting a specific part of the brain connected to relaxation and calmness. The goal of the study is to see how CBD can impact brain functions related to inhibiting anxiety and controlling behavior in people with FXS using advanced imaging techniques.

To participate in this trial, individuals must be between 7 and 55 years old, have a confirmed diagnosis of FXS, and meet certain health criteria, such as having an IQ below 70 and specific behavior scores. The trial is open to both individuals with FXS and a control group of healthy participants aged 18 to 55. Participants will undergo health screenings and will take CBD in a controlled setting while researchers monitor their brain activity. It’s important to note that this trial is not yet recruiting participants, so there will be more information available as it progresses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Eligibility criteria for FXS participants will include:
• • age between 7 and 55 years, molecular diagnosis of FXS,
• • intelligence quotient (IQ) \<70,
• • aberrant behavior questionnaire score (ABC-C) \> 20,
• • \<3 psychoactive drugs, drug stable for \> 3 months.
• Eligibility criteria for the control group:
• • 18 and 55 years old,
• • be in good general health, with no history of neurological or psychiatric disorders.
• Eligibility Criteria for all Participants:
• • A minimum weight of 60 kg;
• • no history of liver problems (A complete blood profile to measure liver enzyme levels (bilirubin, aspartate aminotransferase (AST), argininosuccinate lyase (ASL), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)) will be obtained before randomization for all participants).
• Exclusion Criteria:
• • The presence of an absolute contraindication to the use of TMS and MRI / MRS (ie presence of metal in the head).
• • Individuals with ALT / ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline,