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living with pain cbd clinical trials

CBD is emerging as a promising pharmaceutical agent to treat pain, inflammation, seizures, and anxiety without the psychoactive effects of THC. Our understanding of the role of CBD in pain management continues to evolve, and evidence from animal studies has shown that CBD exerts its pain-relieving effects through its various interactions and modulation of the endocannabinoid, inflammatory, and nociceptive (pain sensing) systems. The endocannabinoid system consists of cannabinoid receptors that interact with our own naturally occurring cannabinoids. This system is involved in regulating many functions in the body, including metabolism and appetite, mood and anxiety, and pain perception.

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What’s the research that CBD works in humans?

If you ask health care providers about the most challenging condition to treat, chronic pain is mentioned frequently. By its nature, chronic pain is a complex and multidimensional experience. Pain perception is affected by our unique biology, our mood, our social environment, and past experiences. If you or a loved one is suffering from chronic pain, you already know the heavy burden.

If you or someone close to you is considering trying CBD, I would recommend Dr. Robert Shmerling’s advice about the dos and don’ts in choosing an appropriate product. Until there is high-quality scientific evidence in humans, it is difficult to make a recommendation for the regular use of CBD in chronic pain management.

Given its promising results in animal models, along with its relative safety, non-psychoactive properties, and low potential for abuse, CBD is an attractive candidate to relieve pain. Unfortunately, there is a lack of human studies about the effectiveness of CBD. However, there is an abundance of commercial advertisements about the magical effects of CBD, and it is frequently presented as a cure-it-all potion that will treat everything including diabetes, depression, cancer, chronic pain, and even your dog’s anxiety!

Medical cannabis Medical cannabis is the term for medications derived from dried cannabis plants in the form of capsules, pills or extracts/oils. The top shoot of the plant contains 100 cannabinoids that are divided into two subgroups; Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), affecting the cannabinoid type 1 receptors located in the central nervous system, and the cannabinoid type 2 receptors located outside of the central nervous system. While the THC cannabinoids have psychoactive, appetite stimulating and nausea reducing effects, cannabidiol has anti-inflammatory, anti-convulsive and immune modulating effects. Studies are inconclusive regarding the effect of cannabidiol on appetite and food intake. Cannabinoids are known to be highly lipophilic and to accumulate in fatty tissue, and may influence the metabolism, fat distribution and accumulation in users. It has been implicated that both TCH and CBD have pain reducing effects. CBD is confirmed to have a favorable safety profile compared to THC.

Eligible participants, who are included at screening, will be randomized in a 1:1 manner to receive either cannabidiol 50 mg or placebo. Allocation will also be stratified based on sex (male vs. female), age and pain intensity (over vs. under 7 on the Fibromyalgia Impact Questionnaire Revised version (FIQ-R) pain numeric rating scale, to ensure that the groups are equal. A computer-generated randomization sequence will create subject identification numbers and allocate the subjects to treatment arms. The randomization sequence will be created by an independent biostatistician using a random number generator (SAS Proc Plan), and subsequently entered in the electronic Case Report Form (e-CRF), that will be developed specifically for the study, by an independent data manager. If unblinding of a participant is required due to an adverse event, the primary investigator can request to break the randomization code for the individual patient, via the independent data manager. The unblinding will always be performed at patient level and unblinding can take place any time during the day (24/7). Randomization and concealed allocation are done electronically in the e-CRF at the randomization visit (week 0).

BACKGROUND: Fibromyalgia is a serious chronic pain condition affecting 2-5 % of the background population. The disease burden in most affected individuals is substantial; with widespread musculoskeletal pain, high pain intensity, often accompanied by sleep disturbances, fatigue, cognitive dysfunction, and emotional distress. Fibromyalgia is associated with disability and muscle fatigue, affecting daily life activities, leading to poor social participation and incapacity for normal employment. Studies have shown that many patients, are not satisfied with the treatments offered, and rate their health and quality of life after treatment as poor.

The study will be conducted at the Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen. The Parker Institute is a well-established research institute and clinical department with secretariat, data managers and Good Clinical Practice (GCP) trained health care professionals including physicians and study nurses. Monitoring will be conducted from the initiation and throughout the trial by the GCP-unit at Bispebjerg and Frederiksberg hospital, in accordance with the GCP rules and regulations.

The US Food and Drug Administration (FDA), has approved Epydiolex® as the first prescription cannabis drug derived from the cannabis plant, for treating rare and severe forms of epilepsy. Synthetically manufactured cannabis such as dronabinol (USA) and nabilone (USA and UK), have been approved earlier in the treatment of nausea after chemotherapy. The only synthetic cannabis based approved drug in Denmark is Sativex® for the treatment of multiple sclerosis. However, none of the cannabis drugs are currently approved for the treatment of chronic pain conditions.