Phase 2
N=17
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Tourette Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03066193 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Changes in Tic Severity — 7.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dronabinol and Palmitoylethanolamide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Tic Severity |
7.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03066193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.