A pilot randomised controlled trial testing the efficacy of cannabidiol for anxiety in Tourette Syndrome

Phase 3

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

• Registration Number: ACTRN12621001659897
• Lead Sponsor: Children's Health Queensland Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-01
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Male or female children/adolescents aged 6-17 years old.
- Participants must have a diagnosis of Tourette Syndrome [confirmed by psychiatric diagnosis], and who have either (1) trialled a course of pharmaceutical (e.g. Clonidine), and psychological (e.g. cognitive behavioural therapy) treatment unsuccessfully; or, (2) who have significant contra-indications to standard methods of treatment
- Participants must be experiencing severe symptoms of anxiety as assessed by the PI at screening
- If participants are receiving non-pharmacological educational, behavioural, and/or dietary interventions, they must be stable and have been doing so for 2 months prior to screening.
- Participants must be willing to continue to be reviewed by their primary treating doctor/psychiatrist/paediatrician during the trial.

Exclusion Criteria

- Use of any cannabis-based product within a month prior to the screening visit (confirmed via urine test at screening).
- Planned use of any cannabis-based product (or other investigational drug) other than that offered in this trial for the planned duration of this trial.
- History of treatment for, or evidence of, drug abuse within the past year.
- History of suicidal behaviour and active intent.
- Participants with pre-existing cardiac conditions or abnormalities.
- Known allergy to CBD or any other cannabinoid and the excipients (ethanol, sucralose, strawberry flavour, sesame oil).
- Participants currently using strong CYP 3A4 inhibitors/inducers or sensitive substrates which may interact with CBD
- Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the PI, preclude study participation or interfere with the evaluation of the study treatment.
- Participants experiencing acute or progressive neurological disease, psychiatric disorder or severe cognitive abnormalities that are likely to require changes in drug therapy, interfere with the objectives of the trial, or interfere with the ability to adhere to protocol requirements.
- Females who are pregnant, nursing or are planning a pregnancy. Cannabidiol is contraindicated in pregnancy. Females of childbearing potential will require a negative serum pregnancy test before participating in the study. Females of childbearing potential must also be willing to use a suitable contraceptive during the trial if they plan on being sexually active. Urine pregnancy tests will be conducted and must remain negative to be permitted to continue the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified