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

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Brief Title

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

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).

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Changes in Tic Severity

Condition

Tourette Syndrome

Intervention

Dronabinol and Palmitoylethanolamide

Study Arms / Comparison Groups

 Dronabinol and Palmitoylethanolamide
Description:  All participants will be titrated up on Dronabinol dose during the first week of the trial (2.5mg Dronabinol for 3 days and then 5mg Dronabinol for 4 days increasing to 10mg Dronabinol for the remainder of the trial). Dronabinol will only be increased to 10mg at the week 1 assessment if the subject is tolerating the 5mg dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. All participants will receive two 400mg tablets of PEA daily for the same 12 weeks that they receive the Dronabinol.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

17

Start Date

February 1, 2017

Completion Date

June 28, 2018

Primary Completion Date

June 28, 2018

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

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Michael H. Bloch, MD, MS, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03066193

Organization ID

1610018525

Responsible Party

Sponsor

Study Sponsor

Yale University

Collaborators

 Therapix Biosciences Ltd.

Study Sponsor

Michael H. Bloch, MD, MS, Principal Investigator, Yale University

Verification Date

February 2020