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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT05115318

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome Cannabis	Drug: Medical Cannabis

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Adult Tourette syndrome patients Patients will be assessed before (baseline), 4 (visit 2) and 12 weeks (visit 3) after use of Medical cannabis via inhaled dried buds or sublingual oil extract. The percentage of THC and CBD were pre-set to 10% and 2%, respectively. All patients received the same general instructions for treatment titration, which was to start with 1 drop or puff a day and increase by 1 drop or puff as needed. There was no fixed schedule for the incremental increases, thus each patient freely raised the dose as well as number of daily consumptions until clinical benefit was achieved or SE emerged over a follow-up period of 12 weeks.	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

Arm

Intervention/Treatment

Adult Tourette syndrome patients

Patients will be assessed before (baseline), 4 (visit 2) and 12 weeks (visit 3) after use of Medical cannabis via inhaled dried buds or sublingual oil extract. The percentage of THC and CBD were pre-set to 10% and 2%, respectively. All patients received the same general instructions for treatment titration, which was to start with 1 drop or puff a day and increase by 1 drop or puff as needed. There was no fixed schedule for the incremental increases, thus each patient freely raised the dose as well as number of daily consumptions until clinical benefit was achieved or SE emerged over a follow-up period of 12 weeks.

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

Outcome Measures

Primary Outcome Measures

Change in vocal and motor tics and disease burden [Baseline, after 4 and 12 weeks since treatment initiation]
Using Yale Global Tic Severity Scale (YGTSS), range 0-100, higher scores mean a worse outcome
Change in premonitory urge [Baseline, after 4 and 12 weeks since treatment initiation]
using Premonitory Urge for Tic Scale (PUTS), range 0-36, higher scores mean a worse outcome
Subjective improvement of tics and Quality of life [Baseline, after 4 and 12 weeks since treatment initiation]
Using a 7-point Likert-type scale, range 1-7, higher scores mean a better outcome

Secondary Outcome Measures

Examine patient's tetrahydrocannabinol-9-delta (THC) and Cannabidiol (CBD) consumption per month [After 12 weeks since treatment initiation]
Measuring total THC and CBD consumption per month in grams
Assessment of major side effects of treatment [After 4 and 12 weeks since treatment initiation]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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