Phase I Pilot study of Medicinal Cannabis (MC) in adolescents with Tourette Syndrome (TS).

Phase 1

Completed

• Conditions: Tourette Syndrome; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12622000031763
• Lead Sponsor: South Western Sydney Local Health District

Brief Summary

Project Summary: Exploring the Impact of Cannabis Oil Treatment on Tics and Quality of Life in Adolescents with Tourette Syndrome. Primary Research Question: How does treatment with cannabis oil affect tics-related symptoms and quality of life in adolescents with Tourette Syndrome (TS)? Background: Tourette Syndrome (TS) is a neurodevelopmental disorder characterized by motor and vocal tics. Traditional treatments such as behavioral therapy and pharmacological interventions while beneficial in controlling the symptoms, these may not be universally effective and can have undesirable side effects. Cannabis has hence emerged as a potential alternative treatment option for TS. Preliminary studies have suggested beneficial effects in adults with TS but this has not been systematically studies in young people. This research project aims to address this evidence gap. Participants and methods: A total of ten male participants aged between 12 and 17 years participated in this trial using medicinal cannabis [tetrahydrocannabinol (THC): cannabidiol (CBD) 10:15] oil. Results: The treatment was accessible and feasible and there were improvements in tic symptoms and quality of life as per comparisons between baseline and day 29 assessment. Limitations: The study is limited by its small sample size. Conclusion: This project suggests potential benefits of Cannabis in TS but future research with large scale randomised controlled trials are indicated.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-14
• Study Completion: 2023-10-11
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Males and females aged 12 – 18 years of age;
DSM-5 diagnosis of TS as assessed by the study clinician.
TS severity defined as a score of 20 out of 50 or higher on the Total Tic Severity section of the YGTSS;
No changes in either medication or other interventions in the 4 weeks prior to enrolment, and intention to remain on the same dose for the duration of the study;
Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;
Agrees not to drive for the duration of the study.

Exclusion Criteria

Non-English speaking parents;
Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder; or a family history of psychosis;
Taking anti-epileptic medications which interact with medicinal cannabis (e.g. clobazam, topiramate, zonisamide);
Abnormal liver function tests defined as ALT > twice ULN;
Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening
Pregnant or intending to become pregnant during the study, or breastfeeding.
History of clinically significant suicidal thoughts in the prior 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified