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Parkinson’s Foundation Consensus Statement on the Use of Medical for Parkinson’s

2020 Parkinson’s Foundation Consensus Statement on the Use of for Parkinson’s Disease

Published by the Parkinson’s Foundation May 2020 Contents

Parkinson’s Foundation Consensus Statement on the Use of Medical Cannabis for Parkinson’s Disease ...... 5 Top Takeaways on the Use of Medical Cannabis for PD..... 6 About Cannabis and Available Products...... 6 Available Evidence for Using Medical Cannabis for Parkinson’s...... 8 Drawbacks of Previous Study Findings ...... 8 Possible Benefits of Cannabis...... 9 Potential Side Effects and Safety Issues ...... 9 We Need More Rigorous Research...... 11 Areas of Interest for Future Researchers...... 11 Guidance for Using Cannabis for Parkinson’s...... 13 Obtaining Medical Cannabis Through a ...... 14 Obtaining A Medical License ...... 14 The Parkinson’s Foundation thanks the following Medical Cannabis Working Group members for their input and time in generating this statement:

Benzi Kluger, MD, MS, University of Rochester – Co-Chair A. Jon Stoessl, MD, University of British Columbia – Co-Chair James Beck, PhD, Parkinson's Foundation Danny Bega, MD, Northwestern University Jacquelyn Bainbridge, PharmD, FCCP, University of , Denver Joseph Jankovic, MD, Baylor College of Medicine Beth Vernaleo, PhD, Parkinson’s Foundation Parkinson’s Foundation With an array of non-motor and motor Consensus Statement on the symptoms, many people with Parkinson’s disease have looked to medical cannabis Use of Medical Cannabis for to provide some relief. However, little Parkinson’s Disease is known about the effects of medical cannabis for Parkinson’s symptoms or With the growing availability of medical the potential side effects and safety marijuana and other medical cannabis issues. To address this, the Parkinson’s products in the , there has Foundation convened a group of experts been a marked increase in its use for on March 6-7, 2019 in Denver, CO, to various medical conditions. Currently, discuss available evidence for the use of medical cannabis is legal in 33 states and cannabis for PD, and gaps in knowledge. the District of Columbia, as well as the This group of more than 40 individuals U.S. territories Guam, Puerto Rico, the included , basic scientists, Northern Mariana Islands and the U.S. a pharmacist, a PD nurse, industry Virgin Islands. Of these, 17 states list members, non-profit organizations, the Parkinson’s disease (PD) as a qualifying PD community and Foundation staff. condition: CA, CT, FL, GA, IL, IA, MA, MO, NH, NM, NY, OH, OK, PA, SC, VT and WV. The primary goal of this statement is (CBD) and products to provide guidance to both people with (defined as having less than 0.3% Parkinson’s and their physicians for the - THC) are legally safe use of medical cannabis for PD. available in all 50 states. A secondary goal is to uncover gaps in knowledge that should be addressed through rigorous research studies. Regardless of whether a medical cannabis product is approved for Parkinson’s in the future, this will help to inform its use for PD so that it is used in the safest, most effective way possible.

Parkinson’s Foundation 1.800.4PD.INFO (473-4636) 5 Top Takeaways on the Use of Medical Cannabis for PD

With increased availability of medical cannabis in the US, and increased interest in the PD community, the Parkinson’s Foundation wanted to provide a document to guide our community in making informed decisions about using cannabis for PD.

1. Our experts urge caution: there are adverse effects, issues, and to drug interactions, and we don’t fully know what this means for people with PD who are taking PD medications. 2. Given the lack of any clear data supporting the use of cannabis in PD, the Foundation does not endorse their use for PD symptoms or to modify disease progression. However, because we realize that people with PD are interested in trying cannabis products, we are providing guidance for both general safety as well as working with . 3. Some studies have suggested cannabis may be beneficial for non-motor symptoms such as sleep disturbances, pain, anxiety, and gastrointestinal issues. However, these studies are generally small, uncontrolled (meaning there is no placebo comparison, which increases the risk of false positive results), and are open label (meaning both the health providers and patients are aware of the drug or treatment being given, which could influence the results). More rigorous research is needed to determine if there is any medical benefit.

About Cannabis and Available effects on a person’s mental state (e.g. Products getting high), and cannabidiol (CBD), which has less of an effect on mental status. Cannabis contains more than 400 different compounds, of which 100 interact with receptors compounds called cannabinoids in the brain called CB1 and CB2. CB1 have been isolated. The best- is concentrated in the central nervous known cannabinoids are delta-9- system and CB2 is associated with tetrahydrocannabinol (THC), which is modifying inflammatory responses and responsible for cannabis’ more prominent the immune system.

6 There are many different varieties of • Epidiolex®, a plant-based CBD cannabis products. These include: pharmaceutical product, approved • Marijuana, a dried mixture of in 2018 by the FDA as a Schedule cannabis and flowers. It is the V drug for the treatment of two most widely used cannabis product juvenile forms of epilepsy, Lennox- recreationally and medically and can Gastaut syndrome and Dravet be smoked, vaporized, or ingested syndrome. Schedule V are orally. considered by the Drug Enforcement • HU-210 is a synthetic street Administration (DEA) to have a also referred to currently accepted medical use in as “spice” or “K2” that is used treatment, but may lead to limited recreationally. HU-210 is 100-800 physical or . times more potent than THC from • and are older cannabis. It is associated with cannabis medications, which are increased toxicity that can be severe synthetic THC drugs used for the and even life-threatening. treatment of cancer-induced / • Hemp is any part of the cannabis , AIDS, appetite stimulation, plant that contains less than 0.3% etc. THC on a dry weight basis and is • Sativex®, is a combination, THC used for its fibrous material or oil for and CBD, pharmaceutical product a number of manufacturing and food approved in Europe. Sativex® is a products. Hemp contains low levels mouth spray intended to alleviate of CBD, but the flowering portions of nerve pain, , overactive hemp can be used to extract CBD. bladder, and other symptoms of • CBD oil is considered a “nutraceutical,” a combination of “nutrition” and “pharmaceutical,” and therefore is not regulated by the U.S. Food and Drug Spray Drops Administration (FDA).

There are several FDA-approved cannabis

pharmaceutical agents that can be Cannabinoid Capsuls Puri ed prescribed for different health conditions. Extract Cannabinoid

Parkinson’s Foundation 1.800.4PD.INFO (473-4636) 7 . Currently in the compare different treatments or other U.S., Sativex® is being evaluated interventions. in Phase III clinical trials to relieve persistent to patients These trials have uniformly failed to find with advanced cancer. evidence of benefit. However, the of lack consistency in the ways the studies were Available Evidence for conducted, the ways in which cannabis Using Medical Cannabis for was given, and the way outcomes were measured, make these studies Parkinson’s inconclusive at best. The studies are further limited by small sample sizes (7 Managing PD symptoms is complex. to 24 patients) and ill-defined placebos, Treating the motor symptoms of the the inert substances used in comparison disease must be balanced against with the treatment. There have been no potential motor complications of published randomized controlled trials of treatments (such as involuntary the effects of smoked cannabis compared movement, known as dyskinesia) to placebo in the PD population. and motor fluctuations—changes in movement associated generally with In 2014 the American Academy of taking levodopa), while also taking Neurology (AAN) Guideline Development into account the impact of non-motor Subcommittee concluded that oral symptoms (such as sleepiness, cognitive cannabis extract is “probably ineffective” impairment and low blood pressure) that for treating PD patients with dyskinesia can also result from therapies. (Koppel et al, 2014). Drawbacks of Previous Study Findings Despite the remarkable popularity of marijuana and the surrounding publicity about its potential medical benefits, there have been only four randomized trials of cannabinoids in patients with PD. In a randomized trial participants are divided by chance into separate groups that

8 Possible Benefits of Cannabis Lung effects In surveys, some PD patients have Different forms of cannabis (such as reported benefits from , edibles and topical forms) have products for tremors, and slow and different effects on the body. Smoking involuntary movement. These benefits or vaporizing cannabis creates smoke or were demonstrated in an open-label vapor that when inhaled can cause issues study of 22 cannabis users and single use with breathing. Chronic, heavy use may of smoked cannabis (Lotan et al 2014). cause damage to the lungs, increasing Many of the subjects in this study also risks of lung cancer and emphysema. noted improvements in ratings of pain and sleep. Although some reports have Toxicity suggested improvement in pain, anxiety, When cannabis is taken orally, the effects sleep problems (such as insomnia), weight usually appear much more slowly and loss, and nausea, no randomized trials last longer than with smoking (after have been performed examining these around 60 minutes, and the effects can factors in PD. last 4-8 hours). Oral cannabis products (edibles) have an increased risk of toxicity We thus do not know whether these because it can take a long time for them reported effects are truly related to to have an effect; their effect lasts a long cannabis use or may represent placebo time; and absorption in the body varies effects or other biases in the study. We for each person. As a result, people may also do not know the optimal or ingest more and more of the product types of cannabinoids to use for PD while waiting for the anticipated effects symptoms. to occur. With many of the oral products, there is a substantial variability in how Potential Side Effects and Safety much THC and CBD they contain. Issues Cannabis has shown promise for Drug interactions alleviating some PD symptoms in animal Cannabis also has several interactions models and in some non-rigorous studies with other drugs. The different liver of cannabis in people that did not that down cannabis compare cannabis with a placebo or other are also the same enzymes that are treatment. However, there are important responsible for the breakdown of other side effects and safety issues to consider. medications. This in turn creates potential

Parkinson’s Foundation 1.800.4PD.INFO (473-4636) 9 drug interactions with cannabis if Other adverse effects taken at the same time as interacting There are several different adverse medications. Drug interactions can effects associated with cannabis potentiate the adverse effects of including short-term memory loss, cannabis (such as sleepiness and anxiety) dizziness, fatigue, behavioral and mood or they can interact by making certain changes, and hallucinations. Cannabis medications more or less effective. is also associated with an increased risk Caution is thus advised and persons on of anxiety and depression. The presence medications should discuss cannabis use of these complications in people with with their doctor or pharmacist. PD is not well established. However, in PD, these adverse effects may have Dependency and more serious consequences. Notable There is a concern about cannabis side effects have been documented in dependency and addiction. Its use can clinical trials including low blood pressure, also result in decreased motivation, which imbalance and fatigue. may become a barrier to promoting and maintaining a healthy lifestyle, especially as apathy may already present a significant problem in PD. In a systematic review conducted by the American Academy of Neurology, 6.9% of participants stopped using cannabinoid products due to adverse effects (Koppel, Neurology, 2014). Controversy surrounds the risk of abuse and the idea of cannabis as a “gateway drug.” Some studies have estimated that up to 10% of cannabis Lack of regulation users may become addicted and There are no federal standards or experience withdrawal symptoms after regulations to ensure correct amounts they stop using it. While it is generally of cannabis in compounds, accurate believed that people cannot overdose on labeling of CBD amounts, or product cannabis, life-threatening complications purity. Studies of compounds obtained have been associated with synthetic through dispensaries found that labels cannabinoids. frequently were inaccurate with products

10 both containing more or less of key of rigorous scientific evidence, and cannabinoids (e.g. THC) than indicated on widespread access to a variety of poorly the label. regulated compounds. In addition, people with Parkinson’s are frustrated that We Need More Rigorous Research many of their symptoms are inadequately “Will marijuana help my PD?” is one of controlled by traditional therapies, while the most frequently asked questions compounds that have been used for by patients, but the answer is not easy medicinal purposes for thousands of (Robledo and Jankovic, 2017). Despite years are inadequately studied and not enormous information in the lay press easily accessible by prescription, and have and social media about the potential no guidelines on use and side effects. benefits of marijuana or various While the frustration (often shared by marijuana products there is a remarkable health care providers) is understandable, lack of scientific, evidence-based data on we must study cannabis as rigorously as the effectiveness and safety of medical we do other treatments. cannabis in PD (Kluger et al. 2015). Areas of Interest for Future There is a huge unmet need to develop Researchers well-designed studies that will address Future research must address several the question of whether cannabis-based questions the Parkinson’s community medicines offer therapeutic benefit in finds pressing. These include: the treatment of motor and non-motor symptoms of PD, levodopa-induced • How might cannabis be useful in the dyskinesia, or even as a treatment to treatment of PD? treat the underlying disease (Peres et al. There is little evidence so far that 2018). that cannabinoids are helpful for levodopa-induced dyskinesias. The number of unanswered questions However, there is some evidence about the use of cannabinoids in PD far that they may help to reduce tremor. outweighs what we know. Complicating It would be helpful to determine if factors include the unusual degree of cannabis might treat distressing non- anecdotal reports (accounts of a person’s motor symptoms of PD, including experience without scientific evidence), sleep disturbances, pain, anxiety and firmly held beliefs despite the absence possibly even stomach problems.

Parkinson’s Foundation 1.800.4PD.INFO (473-4636) 11 toxic effects. Because it takes • Are cannabinoids safe for people with much longer for edibles to have an Parkinsons? effect compared to other forms of Although some people report that cannabis, people are more likely to cannabis helps them with some overdose themselves as they think non-motor symptoms commonly they haven’t taken enough. This associated with PD, there are also is further complicated by lack of concerns that they could cause or information about the concentration, worsen other problems, such as purity, and potential contaminants in cognitive impairment, decision- commercially available preparations making capacity, imbalance, low of CBD. Neither the most beneficial blood pressure, apathy and possibly compounds of marijuana nor the even psychosis and impulse control most effective doses are known at disorders. Data are needed on this time. potential interactions between cannabinoids and medications used • Could cannabinoids be used to treat to treat PD or its complications. the underlying disease? Researchers also should determine Perhaps. Drugs acting on CB2 what other factors contribute to receptors in the brain, which individual variations in response are associated with modifying to cannabis. For example, women inflammatory responses and the respond differently from men immune system, may potentially with respect to changes in pain protect the nervous system in perception. Parkinson’s and other that affect the nervous system. However, • How should cannabis be used? the role of modulating inflammation There is some evidence that CBD in Parkinson’s is not yet established may be more beneficial if it contains and there are no data yet in humans small quantities of THC. The way supporting the use of cannabinoids a person uses cannabis can have for this purpose. a profound impact on response. Edibles, while widely thought to be • What about clinical trials? safer than other forms of cannabis, A few clinical trials are already in fact are often associated with underway but there is much more

12 work to be done. The most promising considered before trying products avenue for now seems to be the use also containing THC. of CBD for the symptomatic relief of non-motor symptoms associated • For pain in one specific area, consider with PD (anxiety, sleep disturbances, creams or patches to reduce general and pain). Preliminary studies need side effects. Be cautious when to combine assessment of the most ingesting edible products, as they effective way to take cannabis, the can have delayed side effects and most effective dose, and a careful increased toxicity. assessment of potential side effects.

Guidance for Using Cannabis for Parkinson’s In the absence of any clear data supporting the use of cannabinoid products in PD, the Parkinson’s Foundation does not endorse their use in PD. However, we recognize that people may decide to try cannabinoid products for certain symptoms. If you decide to try cannabinoid products we suggest: • Consider working with a single dispensary. As these products are • Keep your healthcare providers not regulated, do not assume the informed of any use of cannabinoid “dose” on a label obtained from one products, because they may interact dispensary will have the same effects with other medications and may as one obtained from a different cause side effects that could dispensary. influence your PD care. • Be aware of potential side effects, • Treat cannabis products as you would particularly dizziness, problems with any new medication. Always start at balance, worsening motivation, dry a low dose and go up slowly. CBD- mouth and impaired thinking and only products may also be less likely memory. to cause side effects and could be

Parkinson’s Foundation 1.800.4PD.INFO (473-4636) 13 Obtaining Medical Cannabis • First you may need to visit a Through a Dispensary to complete paperwork for A dispensary is a location one visits to you to get a license. If your primary purchase medical cannabis. They are care physician is not comfortable regulated and taxed according to the filling out this paperwork, there are state they are located. Dispensaries doctors who are licensed to prescribe are not the same as pharmacies in that marijuana for medical use. These you will not get a prescription from your doctors may be associated with doctor for a specific product or dose. dispensaries and often work for a You should work with the person at the cash fee. dispensary to find products that may fit your symptoms. Some dispensaries have • Once the physician paperwork is staff who are interested in medical uses completed, the physician will typically of cannabinoids, but not all have staff submit it online or by mail and then who are equally knowledgeable or helpful. you will be required to apply for As cannabis products are not tightly a license through your state. This regulated, we recommend that you work typically involves proof of state with the same dispensary, as products residency and a small fee. that appear similar based on their labels could have very different concentrations • Once you get your license you can go of cannabinoids and effects in different to a medical dispensary and purchase dispensaries. You may want to talk the products. to people at your support group or shop around to find a dispensary with If you live in a state that has both knowledgeable staff. recreational and medical marijuana dispensaries you have the option Obtaining A Medical Marijuana of getting a license or purchasing License cannabinoid products from the Depending on your state, some recreational dispensary, which does not dispensaries require a medical marijuana require a license. People will sometimes license. While the process to acquire decide to not get a license if they want a medical marijuana may vary, it can to sample these products without going typically include the below steps: through a doctor or if they have concerns about being on a state registry. In

14 general, the products on the recreational side are typically similar to what is available with a license.

Advantages to getting a license may include paying a lower price for products (in Colorado for example you avoid paying a 40% tax by having a license) and the potential of working with staff at dispensaries that may have greater experience in working with older adults and persons with medical issues.

Learn more about Parkinson’s Foundation research at Parkinson.org/Research.

Learn more about Parkinson’s disease and medical marijuana at Parkinson.org/Marijuana.

Parkinson’s Foundation 1.800.4PD.INFO (473-4636) 15