Cannabis, Tourette Syndrome
Conditions
Keywords
Cannabidiol, Cannabis, Medical Cannabis, delta(9)-Tetrahydrocannabinol, Tourette Syndrome
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.
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.
Interventions
DRUGMedical Cannabis
Patients with GTS were assessed before, 4 and 12 weeks after Medical cannabis initiation for consumption habits, efficacy and side effect profile
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Outcome results
None listed