CLINICAL STUDY

CPR420 is currently initiating one of many national clinical study on CBD and seeking willing participants. The principle investigator and facilitator of this study is Dr. David M. Ellison, M.D. 7908 Cincinnati Dayton Rd., Suite J, West Chester, OH 45069,. Dr. Ellison along with CPR420 and the aid of several medical doctors, nurses and clinicians across the country look to provide real data to the general public and medical community regarding CBD.

Title: Efficacy of Cannabidiol to Attenuate Daily Stress and the Perception of Quality of Life in Individuals with High Stress Levels

Purpose of Research

To evaluate the efficacy of an interventional treatment utilizing an herbal ingredient, cannabidiol, to beneficially impact stress, overall mood, and the perception of “quality of life” in individuals with high stress levels.

Background and Hypothesis

Uncontrolled stress is a global health problem and is associated with significant adverse health consequences, both physical and emotional. The term “stress” has limited usefulness from a scientific and medical standpoint due to its highly subjective definition. To help objectify the term, “stress” can be thought of as “a state of mental or emotional or physical tension or strain that results from an adverse internal or external stimulus.” The physiologic stress response, for example — that response that would occur if one were to turn the corner and encounter a bear, is well characterized. For the purposes of this study, the author has defined stress as an “unwanted and unpleasant state of mind resulting from adverse emotional or external influences.” Stress can be mild or severe.

People typically associate the word “stress” with negative state. Stress, however, is adaptive, productive and good. Without it, human beings would not be motivated to do anything. Increasing levels of stress are associated with increasing levels of performance, and its presence is not necessarily linked to uneasy feelings. When stress is too high, however, its emotional impact to the individual experiencing it can become unpleasant. Stress can be useful as a motivator such as when one needs to awaken from the sound of an alarm clock, on one hand, or when one needs to flee from mortal danger at the other end of the spectrum. When stress is too high for a prolonged period of time, termed chronic stress, it is maladaptive and its physiologic consequences can have untoward mental and physical consequences, including sleep disturbance, headache, fatigue, diabetes, obesity, coronary artery disease, hypertension, anxiety and depression.3,4,5 Chronic stress is the major endpoint of interest for this study, and the author wishes to study outcomes in persons who subjectively rank their average daily stress level as “higher than normal” using cannabidiol (CBD), and extract of the cannabis sativa plant.

There are a number of pharmaceutical and behavioral treatments for chronic stress. Pharmaceutical interventions include anxiolytics, such as benzodiazepines, and antihistamines, antidepressant medications, and other medications that aim to effect neurotransmitter balances in the brain. Pharmaceutical interventions can be associated with significant side effects including potentials for addiction and abuse. A lack of intervention, on the other hand, can be associated with significant morbidity, and even mortality. It would be desirable to have a naturally occurring compound with little or no side effects that could beneficially impact the users perception of daily stress levels and overall mood, thus improving subjective quality of life ratings. CBD, administered orally or by inhalation, has promise to be that intervention meeting the above criteria.

Cannabidiol (CBD) is a cannabinoid extracted from the cannabis sativa plant. This genus of plant encompasses different varieties that include hemp and the colloquially so-called “marijuana” plant. The two are part of the same plant family and distinguished by the relative amount of delta-9-tetrahydrocannabinol (THC) (The psychoactive component of the plant that can render one “high”) that the plant contains. One should not confuse the words, “cannabis,” “hemp,” and “marijuana.” Although there is overlap in these terms, they are not synonymous. Importantly, the ingestion of hemp is not associated with psychoactive effects.

The cannabis sativa plant, is one of the earliest known plants to be used by humans for medicinal purposes. It has a rich history as a medicinal owing to its analgesic, anti-inflammatory and anti-emetic effects. It has a number of documented physiologic effects that are exerted through a variety biochemically active compounds known as cannabinoids. Recent discoveries have shown that cannabinoids exert their effects mainly through receptors (CB1 and CB2 receptors) throughout the body. Discovery of these receptors opened the doors to the discovery of the endocannabinoid system (ECS), a physiologic system which encompasses: (1) cannabinoids naturally produced by the body (endocannabinoids); (2) their corresponding receptors, CB1 and CB2, and; (3) exogenous ligands to these receptors, namely the naturally occurring cannabinoids of the cannabis sativa plant and their synthetic analogs. Research of the endocannabinoid system reveals that is has a regulatory role in: memory, motor learning, energy and metabolism, appetite, stress response, neuroregulatory responses, sleep, pain sensation, immune function, among others. It is an important physiologic system in vertebrates, including humans.

Socially, cannabis is best known for its psychoactive properties (it’s ability to make people “high”), and this effect is accounted for by the cannabinoid delta-9-tetrahydrocannabinol (THC) binding to the CB1 receptor in the brain. To date numerous studies have been completed showing promise for using cannabis medically for a number of disorders including: seizure disorder, alzheimers disease, cancer, chronic pain, autism, post traumatic stress disorder gastrointestinal disorders, multiple sclerosis, neurodegenerative disorders and others. There remains debate in the medical community regarding the true value of cannabis to treat varying disorders, and many agree that further research is needed to ascertain efficacy and treatment guidelines. Part of the historic problem with collecting research data is owed to the fact that, because of the psychoactive properties of the cannabis plant, cannabis was criminalized by the United States federal government in the 1930’s and subsequently classified as a schedule 1 substance. In the United States drugs are classified into one of five categories. Schedule 1 substances are defined as: “having a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use of the drug or other substance under medical supervision.”

The cannabis sativa plant contains other cannabinoids other than THC. In fact the family of phytocannabinoids is comprised of over 60 compounds. One of the cannabinoids, cannabidiol (CBD) which is not psychoactive, has growing evidence of medical benefits. It is receiving attention for its promise to remedy a number of medical disorders owing to its anxiolytic, antipsychotic, antiemetic, anti-oxidant, anti-convulsant, and anti-inflammatory properties.1,2 To date many studies have been performed in animal models, and there is a need for more human studies. Currently two human trials looking at the use of CBD in seizure disorder and schizophrenia are underway using a pharmaceutical version of the molecule. The UK-based company GW Pharmaceuticals who developed the drug is funding the studies. Some studies support the use of CBD, even in high doses (1500mg/day), without any side effects. Other studies, however, show CBD may be associated with inhibition of hepatic drug metabolism, decreased fertilization capacity, and decreased activity of certain drug transporters. Recent studies involving consumption of CBD in controlled doses show no adverse effects.

The author of this study wishes to conduct clinical trials using naturally occurring CBD-containing compounds. In addition to examining any beneficial effects for stress and anxiety, it is equally desired to begin establishing dosing protocols. There is much to be learned about CBD and it’s potential role to beneficially impact a number of medical conditions. The preliminary research results are both exciting and promising. Even after well established outcomes and dosing guidelines are in place, we will still need to learn the additive and synergistic of different cannabinoids used in combination. Although research designs such as this one are limited by their use of isolated cannabinoids they will also help establish baseline data for comparison as the body of research grows.

The need for safe and efficacious medicinal or nutraceutical interventions for chronic daily stress and mild anxiety whose levels are sufficient enough to subjectively negatively impact quality of life is great and presently unmet. Most currently available medicinal or nutraceutical options are either associated with significant adverse side effects and habit-forming potential or have a lack of evidence to support their use. Preliminary evidence supports the use of CBD to help with daily stress and/or mild anxiety, and more human studies are needed to add to the existing data and to help establish dosing guidelines.
The investigator of this study asserts the following: (1) that chronic high daily stress levels are prevalent in the United States; (2) that mainstream medicine provides no ideal options for the management of daily stress or mild anxiety; (3) that other options are needed for the management of these conditions; (4) that cannabidiol is associated with promising evidence as a beneficial intervention for these conditions and has low side effects: (5) and that additional human trials are needed to help establish cannabidiol’s role in treating these conditions and for its dosing guidelines.

Hypothesis: cannabidiol, as a dietary supplement, administered at a sufficient dosage will beneficially impact chronic daily stress, overall mood, and subjects’ overall perception of quality of life.

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