Trial of Cannabis for Essential Tremor

University of California San Diego

Status and phase

Completed

Phase 2

Phase 1

Conditions

Essential Tremor

Treatments

Drug: CBD/THC

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03805750

180414

Details and patient eligibility

About

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.

Full 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 tremors that occur when an individual moves. The tremors most commonly affect the hands, head, voice, and legs in order of frequency, leading to impairment in activities of daily living and morbidity. No pharmacological agent has been developed for ET, though existing agents such as propranolol and primidone are used off-label to reduce tremor amplitude. Deep brain stimulation surgery is often reserved for only individuals with the most severe tremors. Patients with ET have long reported tremor benefits with the use of cannabis, though no controlled trials have been conducted. The investigators plan to conduct the first double-blind, placebo-control clinical trial of cannabis in an oral capsule. Various validated tremor rating methods will be used to quantify tremor severity, while looking at tolerability and safety.

Enrollment

7 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)