Clinical trial NCT03066193: Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome
Official title: Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tourette Syndrome
Keywords: Motor tics
Vocal tics
Cannabinoids
Dronabinol
PEA
Palmitoylethanolamide
Tourettes
TS
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: SciSparc
First posted: 2017-02-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators propose a 12-week, investigator-initiated, open-label trial of a therapeutic combination of Dronabinol and PEA in 18 adults with Tourette syndrome. Participants will receive Dronabinol and PEA in combination for the duration of the trial. The goal for this pilot study is to (1) provide initial safety, feasibility and tolerability data on both Dronabinol and PEA in a TS population and (2) provide data in order to make a more informed decision regarding the appropriate sample size and design of a larger clinical trial to prove efficacy (i.e. sample size and trial duration in large efficacy trial of the Dronabinol/PEA combination in TS).

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

Primary outcomes:
measure: Changes in Tic Severity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Michael H. Bloch, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: