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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

Tracking Information
First Submitted Date October 16, 2021
First Posted Date November 10, 2021
Last Update Posted Date November 10, 2021
Actual Study Start Date July 1, 2020
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2021)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 29, 2021)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome
Official Title The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with resistant Tourette syndrome
Condition
  • Tourette Syndrome
  • Cannabis
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
Study Groups/Cohorts 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.
Intervention: Drug: Medical Cannabis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 29, 2021)
18
Original Actual Enrollment Same as current
Actual Study Completion Date March 31, 2021
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT05115318
Other Study ID Numbers 0491-10-TLV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Tel-Aviv Sourasky Medical Center
Original Responsible Party Same as current
Current Study Sponsor Tel-Aviv Sourasky Medical Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date October 2021