Status:
COMPLETED
Trial of Cannabis for Essential Tremor
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
International Essential Tremor Foundation
Tilray
Conditions:
Essential Tremor
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.
Detailed Description
Essential tremor (ET) is the most common neurological movement disorder, affecting up to 1% of the population and up to 5% of individuals over the age of 65. ET is characterized by often disabling tre...
Eligibility Criteria
Inclusion
- Diagnosis of ET by a Movement Disorder Neurologist
- Stable dose of tremor medication for a period of at least 6 weeks prior to screening
- Tremor in the arms
- Tremor(s) is/are moderately severe (amplitude of at least 1cm)
Exclusion
- Significant non-ET related abnormal findings on neurological exam
- Tremor at rest, or other features suggestive of Parkinson disease
- Diagnosis of dementia
- Pregnant or nursing
- Childbearing potential and unable or unwilling to use contraception during course of the trial
- On medications known to interact with the study drug
- Current or prior history of alcohol or substance abuse
- Recent exposure to primidone (within the past 21 days) or benzodiazepines (such as Valium, Ativan or Klonopin), ketoconazole, ritonavir, clarithromycin, rifampin, carbamazepine, St. Johns Wort, digoxin or other medications known to affect your liver enzymes (within the past 7 days).
- Unwilling to abstain from consuming grapefruits, grapefruit juice or grapefruit containing products.
- Taking medications such as warfarin, cyclosporine, and amphotericin B that are highly protein-bound
- Do not wish to take a cannabis-derived agent
- Allergy or sensitivity to sorbitol, xylitol, stevia or other natural sweeteners
- Allergy or sensitivity to cannabis
- Used cannabis or a cannabis-derived product (such as CBD oil) within the past 4 weeks or plan to use it during this research study.
- Diagnosis of a psychiatric disorder (e.g., mania, bipolar depressive disorder, schizophrenia, schizoaffective disorder, or other major psychiatric disorder)
- Current or prior history of suicidal thoughts and/or behavior
- Active medical problem affecting the immune system, liver, gastrointestinal tract, lungs, heart, endocrine system (such as diabetes and/or thyroid), and/or a blood clotting disorder
- Current infection
- Reduced kidney function (GFR \<60)
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03805750
Start Date
January 22 2019
End Date
November 30 2020
Last Update
October 13 2022
Active Locations (1)
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1
University of California San Diego
La Jolla, California, United States, 92093