FAAH Inhibitor Trial for Adults With Tourette Syndrome
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Tourette Syndrome
In brief
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.
Key facts
- Study ID
- NCT02134080
- Run by
- Yale University
- People needed
- 5
- Starts
- 2014-05-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2018-10-29
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Connecticut Mental Health Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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