INTERVENTIONALCOMPLETEDNCT03066193

Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2020-02-24

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 17 (ACTUAL)
Start date: 2017-02-01
Sponsor: Yale University
Design: NA · SINGLE GROUP · TREATMENT
Locations: 1
Results record: Present in registry snapshot

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).

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol palmitoyl ethanolamide

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL MARINOL Marinol MARINOL

Interventions

What was registered

DRUG

Dronabinol and Palmitoylethanolamide

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.

synthetic Δ9THC · Marinol · C21H30O2 · Δ9-Tetrahydracannabinol · PEA · C18H37NO2 · PeaPure · N-palmitoylethanolamine · MimyX · Impulsin · Normast

Source-reported results

Results posted to the registry

1 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 0
Statistical analyses: 0
Adverse-event terms: 29

PRIMARYChanges in Tic Severity

Time frame: 12 weeks
Measure: MEAN · score on a scale
Reporting status: POSTED

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.

Group	N	Value	Spread / interval
Dronabinol and Palmitoylethanolamide	16	7.6	2.5 to 12.8

Participant flow1 period

Overall Study

Milestone	Dronabinol and Palmitoylethanolamide
STARTED	17
COMPLETED	16
NOT COMPLETED	1

Why participants did not complete

Withdrawal by Subject: Dronabinol and Palmitoylethanolamide 1

Baseline6 measures

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Not accepted

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

primary measures

Changes in Tic Severity

Time frame: 12 weeks

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 7ac1609c-3e6e-4f37-9ecd-c7689bbed0f6
Retrieved: 11/09/2026, 14:16:28
SHA-256: fc55e9ef1f787ef02f1c47764f8f94893fceb3b7b23edb52109041a9fc6d1b3f

Event	System	Groups: affected / at risk
Fatigue/Drowsiness	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 16 / 16
Feeling "high"	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 16 / 16
Dry Mouth	Skin and subcutaneous tissue disorders	Dronabinol and Palmitoylethanolamide: 15 / 16
Dizziness/Lightneadedness	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 13 / 16
Difficulty concentrating	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 13 / 16
Headache	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 11 / 16
Anxiety	Psychiatric disorders	Dronabinol and Palmitoylethanolamide: 11 / 16
Weakness, unsteadiness	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 11 / 16
Warmth or tingly feeling	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 10 / 16
Gaps in memory	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 10 / 16
Ataxia	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 10 / 16
Clumsiness	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 9 / 16
Lack of coordination	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 9 / 16
Depersonalization	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 9 / 16
Increased apetite	Metabolism and nutrition disorders	Dronabinol and Palmitoylethanolamide: 8 / 16
Nausea	Gastrointestinal disorders	Dronabinol and Palmitoylethanolamide: 8 / 16
Exagerated sense or well being	Psychiatric disorders	Dronabinol and Palmitoylethanolamide: 7 / 16
Red eyes	Eye disorders	Dronabinol and Palmitoylethanolamide: 7 / 16
Heavy limbs/muscles	Nervous system disorders	Dronabinol and Palmitoylethanolamide: 7 / 16
Sleep problems (insomnia)	Psychiatric disorders	Dronabinol and Palmitoylethanolamide: 6 / 16
Blurry vision	Eye disorders	Dronabinol and Palmitoylethanolamide: 6 / 16
Decrease in apetite	Metabolism and nutrition disorders	Dronabinol and Palmitoylethanolamide: 6 / 16
Paranoia	Psychiatric disorders	Dronabinol and Palmitoylethanolamide: 6 / 16
Mood changes	Psychiatric disorders	Dronabinol and Palmitoylethanolamide: 5 / 16
Muscle aches/pains	Musculoskeletal and connective tissue disorders	Dronabinol and Palmitoylethanolamide: 5 / 16
Stomach pain	Gastrointestinal disorders	Dronabinol and Palmitoylethanolamide: 4 / 16
Diarrhea	Gastrointestinal disorders	Dronabinol and Palmitoylethanolamide: 4 / 16
Panic attack	Psychiatric disorders	Dronabinol and Palmitoylethanolamide: 4 / 16
Vomiting	Gastrointestinal disorders	Dronabinol and Palmitoylethanolamide: 2 / 16

Examining the Efficacy of a Therapeutic Combination of Dronabinol (Synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide for Tourette Syndrome

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Dronabinol and Palmitoylethanolamide

Results posted to the registry

Overall Study

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Changes in Tic Severity

Locally readable linked articles

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Yale Global Severity Scale (YGTSS)Tic total score at baseline

Dronabinol and Palmitoylethanolamide