Safety and Efficacy of Cannabis in Tourette Syndrome

January 21, 2021 updated by: University Health Network, Toronto

A Double-blind, Randomized, Placebo-controlled Crossover Pilot Trial of Medical Cannabis in Adults With Tourette Syndrome

For many individuals with Tourette syndrome (TS), available medications do not help with their symptoms, or cause significant side effects. Two small controlled trials have investigated the effect of oral delta-9-tetrahydrocannabinol (THC), a principal psychoactive ingredient of cannabis, in TS patients. While these trials have shown promising results, the effect sizes were not as large and consistent as those reported by patients with regards to inhaled cannabis (smoked or vaporized). Indeed, based on anecdotal evidence, patients have much greater improvement in their symptoms using inhaled cannabis than using cannabinoid pharmaceuticals. However, there have been no controlled trials of inhaled medical cannabis for TS to date. Furthermore, various medical cannabis products are authorized in Canada with different contents of THC and cannabidiol (CBD), another primary cannabinoid. No data exists regarding the dosing, efficacy and safety of these products in the treatment of TS. To gather such data, a double-blind, randomized, crossover pilot trial will be conducted to compare the efficacy and safety of three vaporized medical cannabis products with different THC and CBD contents, as well as placebo, in adults with TS. As well, the PK/PD profile of THC and CBD of the products will be assessed and correlated with tic symptoms

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • Toronto Western Hospital - Tourette Syndrome Neurodevelopmental Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female adult, 18-65 years of age (inclusive) at the time of signing the informed consent.
  • The subject meets current DSM-5 diagnostic criteria for TS[6], diagnosed by a neuropsychiatrist with expertise in TS and related conditions.
  • YGTSS-TTS ≥16, frequency subscore = 5 and intensity subscore ≥ 2. In addition, tic free intervals do not last more than two minutes based on both self-reporting and observation by clinician at both screening and Week 0 (randomization). This requirement is for the purpose of minimizing the potential for floor effects given the relatively short window for assessing effect on symptoms in this single-dose trial.
  • The subject is able and willing to refrain from using any non-study cannabis during the screening and treatment phases of the study.
  • Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception (or can confirm abstinence at each scheduled visit), and must not be breast feeding.
  • Written informed consent must be obtained from the subject prior to the initiation of any protocol-required procedures.
  • The subject is able to comprehend and satisfactorily comply with the protocol requirements.

Exclusion Criteria:

  • • The subject and/or his/her family have a history of psychosis, schizophrenia or bipolar disorder.

    • Sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial; Females who are breast-feeding and/or who have a positive serum pregnancy test result prior at the time of screening.
    • The subject represents a significant risk of committing suicide (current suicide plan or attempt in past 2 years) or committing homicide.
    • The subject has a history of serious head injury, seizure disorder, or developmental delay (intelligence quotient≤85).
    • The subject has either of: cardiovascular disease; respiratory disease such as chronic obstructive pulmonary disease (COPD) or lung cancer (asthma is not an exclusionary criterion); hepatitis.
    • The subject has a current or past history of substance abuse within the last 5 years, with the exception of cannabis.
    • The subject is using cannabis regularly for the treatment of TS.
    • The subject has any abnormal laboratory tests and vital sign results which in the investigator's judgment is medically significant and would impact the safety of the subject or the interpretation of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: A (THC 10%, CBD <0.5%), B (THC 8.6%, CBD 8.6%), C (THC 0.6%, CBD 14%) and placebo D (THC <0.3%, CBD <0.3%).
Drug: Cannabis
THC 10%, CBD <0.5%
Other Names:
  • Marijuana
Drug: Cannabis
THC 8.6%, CBD 8.6%
Other Names:
  • Marijuana
Drug: Cannabis
THC 0.6%, CBD 14%
Other Names:
  • Marijuana
Other: 2
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: B (THC 8.6%, CBD 8.6%), placebo D (THC <0.3%, CBD <0.3%), A (THC 10%, CBD <0.5%), C (THC 0.6%, CBD 14%).
Drug: Cannabis
THC 10%, CBD <0.5%
Other Names:
  • Marijuana
Drug: Cannabis
THC 8.6%, CBD 8.6%
Other Names:
  • Marijuana
Drug: Cannabis
THC 0.6%, CBD 14%
Other Names:
  • Marijuana
Other: 3
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: C (THC 0.6%, CBD 14%), A (THC 10%, CBD <0.5%), placebo D (THC <0.3%, CBD <0.3%), B (THC 8.6%, CBD 8.6%).
Drug: Cannabis
THC 10%, CBD <0.5%
Other Names:
  • Marijuana
Drug: Cannabis
THC 8.6%, CBD 8.6%
Other Names:
  • Marijuana
Drug: Cannabis
THC 0.6%, CBD 14%
Other Names:
  • Marijuana
Other: 4
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: placebo D (THC <0.3%, CBD <0.3%), C (THC 0.6%, CBD 14%), B (THC 8.6%, CBD 8.6%), A (THC 10%, CBD <0.5%).
Drug: Cannabis
THC 10%, CBD <0.5%
Other Names:
  • Marijuana
Drug: Cannabis
THC 8.6%, CBD 8.6%
Other Names:
  • Marijuana
Drug: Cannabis
THC 0.6%, CBD 14%
Other Names:
  • Marijuana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rush Video-Based Tic Rating Scale
Time Frame: 10 minutes
Can be used to assess changes in frequency and severity of tics
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Marijuana Effect Expectancy Questionnaire (MEEQ)
Time Frame: 6 hours
To assess tolerability of cannabis products
6 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve of CBD and 11-OH-THC
Time Frame: 6 hours
Determine a temporal relationship between changes in THC/CBD plasma concentrations and tic severity
6 hours
Premonitory Urge for Tics Scale (PUTS)
Time Frame: 1 hour
Assesses the intensity of premonitory urges
1 hour
Clinical Global Impression- Improvement Scale (CGI-I)
Time Frame: 1 hour
Assesses how improved symptoms are after an intervention
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Paul Sandor, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

June 6, 2019

Study Completion (Actual)

January 27, 2020

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-7726

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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