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).
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.
Intervention Type: Drug
Description: Oral formulation of CBD and THC.
Arm Group Label: CBD/THC
Intervention Type: Drug
Arm Group Label: Placebo
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
Minimum Age: 21 Years
Healthy Volunteers: No
Type: Principal Investigator
Investigator Affiliation: University of California, San Diego
Investigator Full Name: Fatta B Nahab
Investigator Title: Associate Professor of Neurosciences
Description: Treatment arm
Type: Placebo Comparator
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.. Clinical Trials Registry. ICH GCP.
Does CBD Calm Essential Tremor? Researchers Are Looking Into It
SAN DIEGO (AP) — The University of California San Diego’s Center for Medicinal Cannabis Research announced Tuesday that the Drug Enforcement Administration has OK’d its plans to import capsules containing two key cannabis compounds — CBD and THC — from British Columbia-based Tilray to study their effectiveness in treating tremors that afflict millions of people, especially those over 65.
The shaking condition affects 10 million Americans. There is no drug to calm it. Researchers want to know if CBD would help.
There is no drug designed to treat essential tremor, a shaking condition. Unlike Parkinson’s disease, which causes shaking when someone is at rest, people with essential tremors shake when they are moving — making everyday activities like writing, drinking and speaking difficult.
The condition afflicts 10 million people nationally and millions more across the globe, according to the International Essential Tremor Foundation.
Many patients try to control the shaking by repurposing other drugs, such as blood pressure medicine, with limited success.
Cannabis has been approved for medical use on a wide variety of conditions in 31 states, but this is the first time scientists have raised the possibility of its effectiveness for calming essential tremor.
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Two Patients Self-Medicated
Dr. Fatta Nahab, a UCSD neurologist and the tremor study’s principal, said he started looking into whether marijuana could be used to treat essential tremor after two patients showed sudden improvement after smoking pot or consuming CBD purchased online.
The FDA application outlined the drug formula — a 20:1 ratio of CBD to THC, to minimize any intoxicating high that study participants might feel — as well as its purity, toxicity, shelf life and other details. Researchers also had to get safety approvals from the university and present their plans to a California research advisory panel.
The university hopes to have 16 to 20 patients in the study, which will begin early next year. Researchers will monitor the tremors with a device placed on the wrist and record changes in the severity of the shaking.
Tilray is providing the drug and limited financial support but said it will have no role in reviewing the study’s results.
“Essential tremor is 10 times more common than Parkinson’s and yet nobody really knows about essential tremor,” Nahab said. “That we’re finally getting to a potential therapeutic option in an area that is untapped is a big deal.”
First Import of Canadian Cannabis
The DEA’s go-ahead marks the first time the US government has approved the importation of marijuana extracts from Canada for a clinical trial, highlighting a new avenue for American researchers who have long had trouble obtaining the drug for medical studies. (Tilray, the supplier, is owned by US-based Privateer Holdings, which also owns Leafly and the cannabis companies Marley Natural and The Goodship.)
NIDA couldn’t supply capsules, so UC San Diego researchers turned to Tilray.
Marijuana remains illegal under federal law, making it impossible for researchers to simply obtain forms of the drug from one of the many medical marijuana programs approved by individual states — even a state with a pot culture as prevalent as California’s.
Instead, federal law dictates that researchers typically must obtain any weed for clinical trials through the National Institute on Drug Abuse, which uses cannabis grown at the University of Mississippi. Scientists have long complained about the difficulty of obtaining that marijuana, as well as its limited quality, variety and usefulness for clinical research.
UC San Diego Needed CBD Capsules
The University of California San Diego researchers said they needed marijuana extracts in capsule form because it’s easier to monitor the doses that patients receive, compared to having patients smoke or vaporize it. They also believed many older patients would be reluctant to participate in the study if they had to inhale the drug, according to Nahab, the UCSD neurologist and tremor study’s principal investigator.
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NIDA doesn’t offer capsules, so the researchers spent about two years going through regulatory hoops to obtain permission to import the drug from Canada, where medical marijuana is federally legal and where recreational sales begin nationwide next month.
Paul Armentano, deputy director of the marijuana law reform organization NORML, said that illustrates how badly American researchers need alternative sources for cannabis. The House Judiciary Committee last week passed a bill to require the Justice Department to issue at least two more licenses to US facilities to grow pot for research.
“It’s very telling that you have researchers in the US willing to exert the patience and go through the regulatory hurdles to make this happen at the same time the United States has its own domestic supply source,” Armentano said.
Marijuana compounds have been imported for clinical trials before, including by Britain-based GW Pharmaceuticals, which won approval this year to sell its purified CBD capsule, Epidiolex, to treat severe forms of epilepsy — the first cannabis drug approved by the US Food and Drug Administration. While GW Pharmaceuticals developed that drug in-house before bringing it to the US for testing, Tilray, which recently became the first marijuana company to complete an initial public stock offering in the US, said it can work with researchers to develop the cannabis formulations they hope to study.
“It’s a really big milestone for Tilray and also just for the whole industry,” said Catherine Jacobson, Tilray’s director of clinical research. “Researchers in the U.S. have really been limited to doing research using dried flower. We have been able to prove to the FDA that we can manufacture investigational study drugs containing cannabinoids that meet their standards.”
Neither the Food and Drug Administration, which regulates clinical trials, nor the DEA had immediate details on how often the agencies have approved the import or use of foreign-made cannabis drugs in research, but DEA spokeswoman Katherine Pfaff said: “It is done. There are definitely situations where, when there’s no source in the U.S., a registrant can import a cannabis-derived drug from another country.”
NIDA: Still Catching Up
The National Institute on Drug Abuse usually provides marijuana as bulk flower or joints to be vaporized or smoked, though it also can supply cannabis oil.
NIDA intends to expand how much marijuana the University of Mississippi grows for research. The agency’s contract with the university provides for the possibility of offering cannabis capsules, but it has not yet done so, said Don Stanford, assistant director of the Research Institute of Pharmaceutical Sciences at the university.
In a groundbreaking agreement, Canadian producer Tilray will export cannabis to researchers at UC San Diego.