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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
7
Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
Matched Placebo
University of California San Diego
La Jolla, California, United States
Digital Spirography
The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.
Time frame: Day 22 (100 minutes post-dose)
Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)
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).
Time frame: Baseline and Day 22
Global Impression of Change
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'.
Time frame: Day 22
Number of Participants Reporting Adverse Events Based on Common Terminology Criteria
Side effects survey
Time frame: Days 1, 3, 6, 22
Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation.
Time frame: Day 22
Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities
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.
Time frame: Day 22
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Accelerometry-based Assessment of Tremor Severity
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.
Time frame: Baseline and Day 22