Title
Trial of Cannabis for Essential Tremor
A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).
Phase
Phase 1/Phase 2Lead Sponsor
University of California, San DiegoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Essential TremorIntervention/Treatment
CBD/THC [cannabidiol (26870), tetrahydrocannabinol (75081)] ...Study Participants
7This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.
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.
Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
Matched Placebo
Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule).
Matched placebo capsule with no active ingredients.
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)
| Event Type | Organ System | Event Term | CBD/THC | Placebo |
|---|
The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.
The performance sub scale of the TETRAS will be used to measure tremor severity. The scale ranges from 0 to 60 points (0 being no tremor).
The Global impression of change will be calculated based on both physician and patient report. The scale ranges from a score of 1 (very much improved) to 7 (very much worse) with a score of 4 indicating 'no change'.
Side effects survey
This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation.
Electrocardiographic changes from baseline measures will trigger further evaluation. EKG's will be rated as normal/abnormal relative to the baseline EKG reading, and abnormal findings will be rated as clinically significant/not clinically significant.
The spectral power density measure of accelerometry data to measure will serve as a measure of tremor severity, comparing tremor amplitude from this digital biomarker at the time of the primary outcome to the same measure at baseline.
