Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Completed · Phase 2
Conditions studied: Tourette Syndrome
In brief
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.
Key facts
- Study ID
- NCT03066193
- Run by
- Yale University
- People needed
- 17
- Starts
- 2017-02-01
- Expected to finish
- 2018-06-28
- Last updated by the study team
- 2020-02-24
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-5 criteria for the diagnosis of Tourette 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)
- 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.
- Taking any co-medications (over the counter or prescription), food supplements/additives which can have a drug interaction with dronabinol or PEA.
- Positive pregnancy test or drug screening test
- History of cannabis dependence
- Significant Medical Comorbidity
- History of hypersensitivity to any cannabinoid or sesame oil
Where it is running
- Yale Child Study Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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