Clinical trial: Trial of Cannabis for Essential Tremor (NCT03805750)

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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment