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Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:
Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome

Clinical Trial Summary

This is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the treatment of adults with Tourette syndrome.

Clinical Trial Description

The investigators propose a 12-week, investigator-initiated, open-label trial of a therapeutic combination of Dronabinol and PEA in 18 adults with Tourette syndrome. Participants will receive Dronabinol and PEA in combination for the duration of the trial. The goal for this pilot study is to (1) provide initial safety, feasibility and tolerability data on both Dronabinol and PEA in a TS population and (2) provide data in order to make a more informed decision regarding the appropriate sample size and design of a larger clinical trial to prove efficacy (i.e. sample size and trial duration in large efficacy trial of the Dronabinol/PEA combination in TS). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03066193
Study type Interventional
Source Yale University
Contact
Status Completed
Phase Phase 2
Start date February 1, 2017
Completion date June 28, 2018
View Details
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