The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05115318|
Recruitment Status : Completed
First Posted : November 10, 2021
Last Update Posted : November 10, 2021
|Condition or disease||Intervention/treatment|
|Tourette Syndrome Cannabis||Drug: Medical Cannabis|
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 Type :||Observational|
|Actual Enrollment :||18 participants|
|Official Title:||The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome|
|Actual Study Start Date :||July 1, 2020|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||March 31, 2021|
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
- Change in vocal and motor tics and disease burden [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Examine patient's tetrahydrocannabinol-9-delta (THC) and Cannabidiol (CBD) consumption per month [ Time Frame: After 12 weeks since treatment initiation ]Measuring total THC and CBD consumption per month in grams
- Assessment of major side effects of treatment [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05115318
|Tel-Aviv Medical Center|
|Tel Aviv, Israel, 5522621|