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Safety and Efficacy of Cannabis in Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT03247244
Recruitment Status : Terminated (Recruitment/enrollment took too long)
First Posted : August 11, 2017
Last Update Posted : January 25, 2021
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE July 25, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date January 25, 2021
Actual Study Start Date  ICMJE January 15, 2018
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
Modified Rush Video-Based Tic Rating Scale [ Time Frame: 10 minutes ]
Can be used to assess changes in frequency and severity of tics
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
The Marijuana Effect Expectancy Questionnaire (MEEQ) [ Time Frame: 6 hours ]
To assess tolerability of cannabis products
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2017)
  • 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
  • Premonitory Urge for Tics Scale (PUTS) [ Time Frame: 1 hour ]
    Assesses the intensity of premonitory urges
  • Clinical Global Impression- Improvement Scale (CGI-I) [ Time Frame: 1 hour ]
    Assesses how improved symptoms are after an intervention
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Cannabis in Tourette Syndrome
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Crossover Pilot Trial of Medical Cannabis in Adults With Tourette Syndrome
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
There are four treatment schemes. All subjects will be randomized in a 1:1:1:1 ratio to one of the four treatment schemes. Participants will receive a single dose of each of the 3 cannabis products + placebo, with the order determine by their assigned treatment arm.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The participants, investigators and analysts will be masked as to the treatment arm and product of each participant and visit. Only the pharmacists will be aware of the strain.
Primary Purpose: Treatment
Condition  ICMJE Tourette Syndrome
Intervention  ICMJE
  • Drug: Cannabis
    THC 10%, CBD <0.5%
    Other Name: Marijuana
  • Drug: Cannabis
    THC 8.6%, CBD 8.6%
    Other Name: Marijuana
  • Drug: Cannabis
    THC 0.6%, CBD 14%
    Other Name: Marijuana
Study Arms  ICMJE
  • 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
    • Drug: Cannabis
    • Drug: Cannabis
  • 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
    • Drug: Cannabis
    • Drug: Cannabis
  • 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
    • Drug: Cannabis
    • Drug: Cannabis
  • 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
    • Drug: Cannabis
    • Drug: Cannabis
Publications * Abi-Jaoude E, Bhikram T, Parveen F, Levenbach J, Lafreniere-Roula M, Sandor P. A Double-Blind, Randomized, Controlled Crossover Trial of Cannabis in Adults with Tourette Syndrome. Cannabis Cannabinoid Res. 2022 Aug 30. doi: 10.1089/can.2022.0091. Online ahead of print.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 21, 2021)
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2017)
Actual Study Completion Date  ICMJE January 27, 2020
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03247244
Other Study ID Numbers  ICMJE 14-7726
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Sandor, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP