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Tourette SyndromePhase 2NCT03247244

Safety and Efficacy of Cannabis in Tourette Syndrome

A Phase 2 study testing Cannabis in people with Tourette Syndrome, run by University Health Network, Toronto at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tourette Syndrome
What is being tested?
Cannabis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
15 Jan 2018to 27 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Western Hospital - Tourette Syndrome Neurodevelopmental Clinic

    Toronto, Ontario, M5T2S8

Other trials in Canada

About this study

Official title: 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

Being tested
Cannabis
Keywords
Cannabis, Tics, Tourette Syndrome
Medical subject headings
Tourette Syndrome, Marijuana Abuse, Tics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabisDrug

    Also called Marijuana

    THC 10%, CBD <0.5%

  • CannabisDrug

    Also called Marijuana

    THC 8.6%, CBD 8.6%

  • CannabisDrug

    Also called Marijuana

    THC 0.6%, CBD 14%

Study groups in NCT03247244
Study groupRoleWhat they receive
1OtherThree 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%).
Receives: Drug: Cannabis
2OtherThree 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%).
Receives: Drug: Cannabis
3OtherThree 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%).
Receives: Drug: Cannabis
4OtherThree 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%).
Receives: Drug: Cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rush Video-Based Tic Rating Scale

    Can be used to assess changes in frequency and severity of tics

    Measured: 10 minutes

Secondary outcomes (1)

  1. The Marijuana Effect Expectancy Questionnaire (MEEQ)

    To assess tolerability of cannabis products

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2017
  2. Study start15 Jan 2018
  3. Primary completion6 Jun 2019
  4. Study completion27 Jan 2020

Why it stopped: Recruitment/enrollment took too long

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03247244
Sponsor's protocol ID
14-7726
Status last verified
Jan 2021
First submitted
25 Jul 2017
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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. 2023 Oct;8(5):835-845. doi: 10.1089/can.2022.0091. Epub 2022 Aug 30.

    PubMed 36040329

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabis in people with Tourette Syndrome, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment/enrollment took too long). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rush Video-Based Tic Rating Scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03247244, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.

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