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

• Status: Completed
• Trial end date: 2018-06-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: SciSparc; Therapix Biosciences Ltd.
• Treatments: Dronabinol; Palmidrol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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