Trial of Cannabis for Essential Tremor

NCT ID: NCT03805750

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2020-11-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CBD/THC

Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule).

Group Type: EXPERIMENTAL

CBD/THC

Intervention Type: DRUG

Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).

Placebo

Matched placebo capsule with no active ingredients.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Matched Placebo

Interventions

CBD/THC

Oral formulation of combined Cannabidiol (CBD) and Tetrahydrocannabinol (THC).

Intervention Type: DRUG

Placebo oral capsule

Matched Placebo

Intervention Type: DRUG

Other Intervention Names

marijuana; cannabis; cannabidiol; tetrahydrocannabinol

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Essential Tremor Foundation

OTHER

Sponsor Role: collaborator

Tilray

INDUSTRY

Sponsor Role: collaborator

Center for Medicinal Cannabis Research

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Fatta B Nahab

Associate Professor of Neurosciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatta Nahab, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California San Diego

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://tremor.cmcr.ucsd.edu

Study Information

Other Identifiers

180414

Identifier Type: -

Identifier Source: org_study_id