Trial of Cannabis for Essential Tremor

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Center for Medicinal Cannabis Research; International Essential Tremor Foundation; Tilray

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)