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Safety and Efficacy of Cannabis in Tourette Syndrome

NCT03247244 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-01-25

No results posted yet for this study

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

Conditions

  • Tourette Syndrome

Interventions

DRUG

Cannabis

THC 10%, CBD \<0.5%

DRUG

Cannabis

THC 8.6%, CBD 8.6%

DRUG

Cannabis

THC 0.6%, CBD 14%

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Paul Sandor, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-06-06
Completion
2020-01-27

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247244 on ClinicalTrials.gov