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

Primary Purpose

Tourette Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dronabinol and Palmitoylethanolamide
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Motor tics, Vocal tics, Cannabinoids, Dronabinol, PEA, Palmitoylethanolamide, Tourettes, TS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dronabinol and Palmitoylethanolamide

Arm 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.

Outcomes

Primary Outcome Measures

Changes in Tic Severity
Yale Global Tic Severity Scale (YGTSS) (Total Tic Score) The YGTSS tool gives ratings in 5 domains: Total Motor Tic Score, Total Verbal Tic Score, Total Tic Score (Motor + Verbal), Overall Impairment Rating, and Global Severity Score. When calculating the Global Severity score, it is found by adding together the total motor, verbal and impairment scores. The Total Tic Severity Score has a range of 0-50, and the Global Severity Score has a range of 0- 100. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2017
Last Updated
February 10, 2020
Sponsor
Yale University
Collaborators
SciSparc
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1. Study Identification

Unique Protocol Identification Number
NCT03066193
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 Ξ”9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
SciSparc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an investigator-initiated proof of concept study with the purpose to examine the safety, tolerability and feasibility of Dronabinol (synthetic Ξ”9-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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Motor tics, Vocal tics, Cannabinoids, Dronabinol, PEA, Palmitoylethanolamide, Tourettes, TS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Participants will receive two active medications and will be followed-up bi-weekly for 12 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dronabinol and Palmitoylethanolamide
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dronabinol and Palmitoylethanolamide
Other Intervention Name(s)
synthetic Ξ”9THC, Marinol, C21H30O2, Ξ”9-Tetrahydracannabinol, PEA, C18H37NO2, PeaPure, N-palmitoylethanolamine, MimyX, Impulsin, Normast
Intervention Description
Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.
Primary Outcome Measure Information:
Title
Changes in Tic Severity
Description
Yale Global Tic Severity Scale (YGTSS) (Total Tic Score) The YGTSS tool gives ratings in 5 domains: Total Motor Tic Score, Total Verbal Tic Score, Total Tic Score (Motor + Verbal), Overall Impairment Rating, and Global Severity Score. When calculating the Global Severity score, it is found by adding together the total motor, verbal and impairment scores. The Total Tic Severity Score has a range of 0-50, and the Global Severity Score has a range of 0- 100. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H. Bloch, MD, MS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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