FAAH Inhibitor Trial for Adults With Tourette Syndrome

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to examine the safety, tolerability and feasibility in the use of a FAAH inhibitor for the treatment of adults with Tourette syndrome.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Tourette Association of America

Criteria

Inclusion Criteria:

• Adult between 18-60 years of age

• Meet DSM IV criteria for the diagnosis of Tourette's syndrome

• Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline

• On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial.

• Accepted method of birth control

Exclusion Criteria:

• Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70).

• Current use of medications that have significant effects on the cannabinoid or dopamine systems. Subjects will be specifically excluded for recent use (within last 8 weeks) of antipsychotic medications, dopamine agonists or psychostimulants.

• Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.

• Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.

• Positive pregnancy test or drug screening test

• History of cannabis dependence

• Significant Medical Comorbidity