NCT03805750

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).

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	CBD/THC	Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
DRUG	Placebo oral capsule	Matched Placebo

Timeline

• Start date: 2019-01-22
• Primary completion: 2020-09-01
• Completion: 2020-11-30
• First posted: 2019-01-16
• Last updated: 2022-10-13
• Results posted: 2022-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study