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NCT Number: NCT05115318

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

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.

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Cannabis Central Nervous System Diseases Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Marijuana Abuse Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Substance-Related Disorders Tic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tel-Aviv Medical Center

Tel Aviv, 5522621, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Cannabis

Drug

Patients with GTS were assessed before, 4 and 12 weeks after Medical cannabis initiation for consumption habits, efficacy and side effect profile

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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