We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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
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.

Layout table for study information
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 : July 1, 2020
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with resistant Tourette syndrome
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Israel
Tel-Aviv Medical Center
Tel Aviv, Israel, 5522621
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Layout table for additonal information
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT05115318    
Other Study ID Numbers: 0491-10-TLV
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tel-Aviv Sourasky Medical Center:
Cannabidiol
Cannabis
Medical Cannabis
delta(9)-Tetrahydrocannabinol
Tourette Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Tourette Syndrome
Syndrome
Marijuana Abuse
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders