The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115318
• Other study ID #: 0491-10-TLV
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2021
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.

Description:

Gilles de la Tourette syndrome (GTS) is a childhood onset neuropsychiatric disorder characterized by the presence of multiple motor and one or more phonic tics continuing for at least one year. In Israel, although consumption of cannabis is outlawed, there is an option to allow patients to consume the drug under supervision. Medical Cannabis (MC) consumed by inhalation of smoked or vaporized dried female buds, or subligual oil extract of whole plant, has been an approved treatment by the Ministry of Health (MOH) for resistant GTS since 2013. Previous studies suggested that MC has a good effect on tics, quality of like and with good tolerability among patients with resistant GTS. In the current study, we prospectively followed-up patients eligible for MC according to MOH restrictions, at our GTS clinic at the Tel-Aviv Sourasky Movement Disorders Unit (MDU). Each subject signed a written informed consent before inclusion in the trial. Also, since driving under the influence of cannabis is forbidden by the Israeli law, patients were instructed and gave their oral commitment to avoid driving. The study was approved by the research ethics (Helsinki) committee at our center. MC was consumed as oil extract, vaporized, or smoked dried buds. The treating neurologist (S.A.) and patient together decided on the method of consumption during the visit before initiating treatment. Patients were assessed 4 and 12-weeks following treatment initiation to gather data regarding treatment efficacy, tolerability and SEs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 - 65 years
• Diagnosis of GTS confirmed by the treating neurologist based on the DSM-V criteria
• Eligibility to receive MOH MC license for GTS
• Provided written informed consent

Exclusion Criteria:

• Regularly use cannabis in any form for self-medication prior to entering the study
• Pregnant or lactating women
• Have a tic disorder other than GTS
• Have concurrent physical or mental disease that could interfere with the study

Related Conditions & MeSH terms

• Cannabis
• Marijuana Abuse
• Syndrome
• Tourette Syndrome

Intervention

Drug:
• Medical Cannabis
Patients with GTS were assessed before, 4 and 12 weeks after Medical cannabis initiation for consumption habits, efficacy and side effect profile

Locations

Country	Name	City	State
Israel	Tel-Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vocal and motor tics and disease burden	Using Yale Global Tic Severity Scale (YGTSS), range 0-100, higher scores mean a worse outcome	Baseline, after 4 and 12 weeks since treatment initiation
Primary	Change in premonitory urge	using Premonitory Urge for Tic Scale (PUTS), range 0-36, higher scores mean a worse outcome	Baseline, after 4 and 12 weeks since treatment initiation
Primary	Subjective improvement of tics and Quality of life	Using a 7-point Likert-type scale, range 1-7, higher scores mean a better outcome	Baseline, after 4 and 12 weeks since treatment initiation
Secondary	Examine patient's tetrahydrocannabinol-9-delta (THC) and Cannabidiol (CBD) consumption per month	Measuring total THC and CBD consumption per month in grams	After 12 weeks since treatment initiation
Secondary	Assessment of major side effects of treatment	report (yes/no) on side effects from list and (free text) to add notes on side effect. List: Anxiety, Cognitive, Dizziness, Sedation, Fatigue, Red eyes; , Dry mouth, Gastrointestinal	After 4 and 12 weeks since treatment initiation