Author Archives: adminoacido

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Availability and approval of cannabis-based medicines for chronic pain management and palliative/supportive care in Europe: A survey of the status in the chapters of the European Pain Federation.

Category : Dolor

Related Articles

Availability and approval of cannabis-based medicines for chronic pain management and palliative/supportive care in Europe: A survey of the status in the chapters of the European Pain Federation.

Eur J Pain. 2017 Nov 13;:

Authors: Krcevski-Skvarc N, Wells C, Häuser W

Abstract
BACKGROUND: There is considerable public and political interest in the use of cannabis products for medical purposes.
METHODS: The task force of the European Pain Federation (EFIC) conducted a survey with its national chapters representatives on the status of approval of all types of cannabis-based medicines, the covering of costs and the availability of a position paper of a national medical association on the use of medical cannabis for chronic pain and for symptom control in palliative/supportive care.
RESULTS: Thirty-one out of 37 contacted councillors responded. Plant-derived tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray is approved for spasticity in multiple sclerosis refractory to conventional treatment in 21 EFIC chapters. Plant-derived THC (dronabinol) is approved for some palliative care conditions in four EFIC chapters. Synthetic THC analogue (nabilone) is approved for chemotherapy-associated nausea and vomiting refractory to conventional treatment in four EFIC chapters’. Eight EFIC chapters’ countries have an exceptional and six chapters an expanded access programme for medical cannabis. German and Israeli pain societies recommend the use of cannabis-based medicines as third-line drug therapies for chronic pain within a multicomponent approach. Conversely, the German medical association and a team of finish experts and officials do not recommend the prescription of medical cannabis due to the lack of high-quality evidence of efficacy and the potential harms.
CONCLUSIONS: There are marked differences between the countries represented in EFIC in the approval and availability of cannabis-based products for medical use. EFIC countries are encouraged to collaborate with the European Medicines Agency to publish a common document on cannabis-based medicines.
SIGNIFICANCE: There are striking differences between European countries in the availability of plant-derived and synthetic cannabinoids and of medical cannabis for pain management and for symptom control in palliative care and in the covering of costs by health insurance companies or state social security systems.

PMID: 29134767 [PubMed – as supplied by publisher]

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More FDA Warnings, Mislabeled CBD Products & Police Raids

Category : Noticias

A series of police raids in North Dakota has set the stage for a courtroom showdown regarding the legal status of cannabidiol (CBD), the non-intoxicating cannabis component with significant medical properties. Thus far, it’s not going well for purveyors of the claim that hemp-derived CBD is legal in all 50 U.S. states.
By Martin A. Lee On November 10, 2017

Highlights: 
  • The FDA has issued more warning letters to hemp CBD companies for making unsubstantiated medical claims.
  • A study published in the Journal of the American Medical Association indicated that 69 percent of hemp CBD products tested did not contain the amount of cannabidiol indicated on the label.
  • Sporadic police raids continue to target CBD retailers in several states.
  • A legal battle over the status of hemp-derived CBD looms in federal court.

A series of police raids in North Dakota has set the stage for a courtroom showdown regarding the legal status of cannabidiol (CBD), the non-intoxicating cannabis component with significant medical properties. Thus far, it’s not going well for purveyors of the claim that hemp-derived CBD is legal in all 50 U.S. states.

In October 2017, Northwest District Judge Robin Schmidt refused to dismiss drug trafficking charges against Falesteni Abuhamda, the owner of two North Dakota tobacco stores, which allegedly sold products containing CBD with very little or no psychoactive THC [tetrahydrocannabinol]. Abuhamda’s attorney argued that the CBD products were legal because the CBD oil was extracted from the stalk of industrial hemp.

But a forensic scientist with the state’s crime lab easily debunked this argument by stating the obvious: CBD is not found in any appreciable amount in hemp stalk. Rather it exudes from the resinous flowers and leaves of the cannabis plant. And, therefore, CBD is forbidden under the Controlled Substances Act, according to the Drug Enforcement Administration (DEA).

FDA saber-rattling

The Food and Drug Administration (FDA), which defers to the DEA on cannabis-related matters, considers CBD to be an experimental pharmaceutical undergoing evaluation. In early November, the FDA sent letters to several companies selling hemp-derived CBD products warning that they were violating the Federal Food, Drug and Cosmetic Acts.

This was the third time in recent years that the FDA has issued warnings to CBD manufacturers and retailers, which market hemp-derived CBD products as nutraceuticals or food supplements. The most recent round of FDA warning letters did not involve false statements about the source of the CBD extracts. Instead, the agency objected to unsubstantiated medical claims allegedly made by four CBD oil producers: Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and last but not least, the Stanley Brothers.

Some of these unsubstantiated claims, according to the FDA, included patient testimonials and assertions that CBD “may be effective in treating tumors from cancer” and other diseases. Thus far, however, there have been no FDA-approved clinical trials that might validate preclinical studies and anecdotal accounts of CBD’s anti-cancer properties.

Today one can easily purchase unregulated CBD products online and at some supermarkets and storefronts across the nation. For the most part, it’s a crapshoot for consumers: A new study published in the Journal of the American Medical Association disclosed that only 31 percent of 84 lab tested hemp-derived CBD products contained the amount of CBD indicated on the label. And who knows what else was in some of these products.

Sporadic raids

While CBD currently seems to be a low priority for federal law enforcement agencies, in recent months there have been sporadic local police raids against CBD retailers in several states besides North Dakota, including (but not limited to):

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Ongoing polics raids
  • Indiana. In April 2017, Governor Eric Holcomb signed a bill allowing people with treatment-resistant epilepsy who register with the state to possess CBD products that contain less than 0.3 percent THC. Shortly thereafter, a law enforcement crackdown on CBD retailers resulted in the seizure of more than 3000 CBD products from about 60 stores throughout the Hoosier State. In August, Indiana’s Alcohol and Tobacco Commission declared a moratorium on CBD raids “unless the products clearly violate Indiana law.” Since the moratorium announcement, Indiana excise police have continued to issue citations to stores selling CBD.
  • Missouri. Vince Sanders, owner of American Shaman, a Kansas City-based wholesaler, supplied CBD products to several stores in Missouri and Kansas. He says his products are legal because they are made from industrial hemp and contain hardly any THC. But Missouri law only allows for low-THC cannabis oil to be sold by manufacturers that are licensed by the state health department, which is not the case for American Shaman.
  • Kansas. Kansas is a zero tolerance state when it comes to THC – hardly any is too much in Kansas. Eddie Smith, owner of Into The Mystic, was surprised when police officers showed up at his alternative medicine store in Mission, Kansas, in May 2017 and confiscated an array of hemp-derived CBD products. During a previous visit, an undercover cop purchased some CBD from Smith’s store. A 22-year-old U.S. Army veteran, Smith protested that he had been told “with 100 percent certainty that [CBD] is totally legal in all 50 states.”
  • Wisconsin. In May 2017, police raided several gas stations in Oshkosh, Wisconsin, which sold CBD products. A month later, police busted two storefronts in Franklin, Wisconsin, for retailing CBD-infused gummies that contained traces of THC. The store owners said that they had been assured by the wholesale CBD vendor that the products were legal to sell and possess. But Wisconsin law stipulates that CBD can only be dispensed by a pharmacist or physician – not a gas station – to a patient who has been certified to possess cannabidiol for treating a specific medical condition.
  • Ohio. In August 2017, police returned 18 bottles of hemp-derived CBD to Poor Boys Smoke Shop in Marysville, Ohio, after a Union County prosecutor declined to press charges stemming from a law enforcement raid two years earlier. Medical marijuana is technically legal in Ohio, but corrupt licensing procedures have stymied patient access to cannabis and CBD-rich products.
  • Nebraska. In September 2017, Nebraska Attorney General Doug Peterson declared that CBD sales in the Cornhusker State are flat-out illegal. But under state law, the University of Nebraska Medical Center has the authority to distribute CBD to certified patients who participate in an experimental research program. CBD commerce outside of the university program is strictly forbidden. “To date no drug products containing CBD have received FDA approval,” Peterson noted.
  • Massachusetts. Two detectives visited Jay’s Smoke Shop in Taunton, MA, to inform the proprietor that it was not okay to sell CBD products at his store, even though residents in the Bay State had voted to legalize cannabis both for medical and adult use. It’s currently legal to possess and use cannabis, including CBD-rich products, in Massachusetts, but not in public or while driving a vehicle. Storefront sales won’t be authorized until 2018 at the earliest.

Complicated laws

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Source: Wikipedia “Legality of cannabis by U.S. jurisdiction”

Currently eight states plus the District of Columbia have legalized cannabis for both medical and adult use; twenty-one more states allow the therapeutic use of cannabis to some degree, but not recreational use; and 18 states have legalized CBD, but not the whole plant or cannabis products containing higher levels of THC. Only three states consider every part of the cannabis plant, including CBD, to be illegal.

Does this mean that cannabidiol is actually legal in most of the United States?

Yes, sort of … maybe.

Confusion regarding CBD’s status stems in part from the patchwork of complicated laws that vary from state to state. But the main problem is Uncle Sam’s abject refusal to acknowledge what has been known throughout the world for centuries: cannabis has significant medical value. Cannabis prohibition, a draconian, racist relic, is based on a mountain of lies, and until this anachronistic policy is terminated, attempts to sort out the legal status of CBD will be mired in contradiction and uncertainty.

Most so-called CBD-only states allow possession of very low or no-THC cannabis products, but do not allow licensed dispensaries, production facilities or home cultivation. In other words, one can possess CBD, but one can’t legally buy it or sell it. Overly restrictive laws in CBD-only states often limit the use of CBD products to children with treatment-resistant seizure disorders.

But even in states with legal protections for CBD users, the substance is still technically forbidden under federal law. Several bills are pending in Congress to extricate CBD from the Controlled Substances Act. Such efforts would not be necessary if CBD was federally legal.

No resin, no THC, no CBD

Undaunted, some CBD proponents believe that cannabidiol is already legal by virtue of a 2004 Ninth Circuit U.S. Appeals Court decision (Hemp Industries Association v. DEA) that struck down the DEA’s attempt to ban hemp food products. But this decision never mentioned CBD and the reasoning behind it undermines the notion that hemp stalk is a viable source of CBD.

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No resin, no THC, no CBD

The Ninth Circuit rejected the DEA’s argument because hemp food products aren’t made from the resin-bearing parts of the plant – the flower tops and leaves – that contain THC and other proscribed cannabinoids.

Hemp-derived protein powder and nutritional supplements are made from hempseed, which has no resin, no THC and no CBD; thus hemp food, according to the Ninth Circuit ruling, is exempt from the Controlled Substances Act.

The DEA lacked credibility when it argued that hemp food should be banned because it comes from hempseed (which is resin-deficient). And today’s CBD hemp companies lack credibility when they try to skirt the law by arguing that their CBD comes from hemp stalk (which is resin-deficient).

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2014 Farm Bill

The Farm Bill exception

The 2014 Farm Bill also makes no mention of CBD, but it is often cited by domestic hemp producers as the reason why CBD is federally legal. The Farm Bill defines industrial hemp as cannabis that contains 0.3 percent THC or less. Cannabis with more than 0.3 percent THC in any part of the plant is considered marijuana and is therefore illegal under federal law.

Most significantly, the Farm Bill carved out an exception to the Controlled Substances Act for industrial hemp that is cultivated under the auspices of a state-sanctioned agricultural or academic research program. (The Farm Bill doesn’t specify what constitutes “research.”) Thus far, twenty-three states have enacted laws pertaining to industrial hemp. And for the first time since World War II, industrial hemp is being grown – supposedly for research purposes –in many parts of the United States.

The Omnibus Appropriations Act of 2016 gave another boost to the fledgling domestic hemp industry by stipulating that federal funds could not be used “to prohibit the transportation, processing, sale or use of industrial hemp that is grown or cultivated in accordance with [the Farm Bill]” – in other words, neither the DEA nor state law enforcement can prevent interstate commerce involving industrial hemp.

Does this mean that CBD oil extracted from hemp grown in Kentucky or Colorado is legal to process, sell and transport across state lines, as long as it doesn’t have more than 0.3 percent THC?

The Hemp Industries Association says yes. The DEA says no.

Legal battle looming

In December 2016, the DEA issued an administrative tracking code for cannabis oil extracts, including CBD concentrates and isolates derived from hemp biomass as well as from marijuana leaves and flower tops. This tracking code did not ban CBD because CBD has always been illegal under the 1970 Controlled Substances Act, which forbids any preparation made from cannabis resin.  All the phytocannabinoids, including CBD and THC, reside in the resinous trichomes of the cannabis plant.

The Hemp Industries Association (HIA) maintains that the DEA failed to recognize the legal distinction between marijuana and hemp, as defined by the Farm Bill, when it announced the new tracking code for cannabis oil extracts. So in January 2017, the HIA filed a judicial review petition that challenged the DEA’s churlish administrative maneuver.

Until a federal judge weighs in, robust CBD commerce will continue in a confusing legal environment, while sports stars and celebrities sing the praises of CBD and medical patients clamor for quality cannabis oil extracts.

About the Author:

Martin A. Lee is the director of Project CBD and author of Smoke Signals: A Social History of Marijuana – Medical, Recreational and Scientific.



1 Even though 0.3 percent THC is an arbitrary political number with no scientific basis, it has become the current standard that much of the world uses to distinguish hemp from marijuana. The 0.3 percent legal limit for THC is based on the work of Canadian cannabis researcher Ernst Small, who wrote The Species Problem with Cannabis. In this book, Small acknowledged that there isn’t a natural dividing point at which cannabinoid content could be used to distinguish hemp from other kinds of cannabis. Nevertheless, he chose 0.3 percent THC as where to draw the line on the continuum of cannabis types.
2 The 1970 Controlled Substances Act defines “marihuana” as “all parts of the plant Cannabis sativa L. [sic], whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil or cake, or the sterilized seed of such plant which is incapable of germination.”

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CBD as Preventative Medicine

Category : Noticias

An excerpt from CBD: A Patient’s Guide to Medicinal Cannabis by Leonard Leinow & Juliana Birnbaum
By By Leonard Leinow & Juliana Birnbaum On November 07, 2017

A new book discusses seven ways CBD-rich cannabis can be used to prevent disease
Highlights: 
  • CBD has anti-inflammatory properties and studies suggest that it can reduce the risk of cancer, metabolic disorders and neurodegenerative disease
  • Low doses of cannabinoids can stimulate the creation of new nerve cells in animal models, even in aging brains
  • CBD has been shown to block an enzyme that destroys bone-building compounds in the body, reducing the risk of age-related bone diseases like osteoporosis and osteoarthritis
  • When applied topically as an infused lotion, serum, oil, or salve, the antioxidants in CBD (a more powerful antioxidant than vitamins E and C) can repair damaged skin

Cannabinoid therapy is connected to the part of the biological matrix where body and brain meet. Since CBD and other compounds in cannabis are so similar to the chemicals created by our own bodies, they are integrated better than many synthetic drugs. According to Bradley E. Alger, a leading scientist in the study of endocannabinoids with a PhD from Harvard in experimental psychology, “With complex actions in our immune system, nervous system, and virtually all of the body’s organs, the endocannabinoids are literally a bridge between body and mind. By understanding this system, we begin to see a mechanism that could connect brain activity and states of physical health and disease.”

Reduced Risk of Diabetes and Obesity

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Regular cannabis users have a lower BMI.

Several studies have shown that regular cannabis users have a lower body mass index, smaller waist circumferences, and reduced risk of diabetes and obesity. One 2011 report published in the American Journal of Epidemiology, based on a survey of more than fifty-two thousand participants, concluded that rates of obesity are about one-third lower among cannabis users. This is despite the findings that participants tend to consume more calories per day, an activity that is potentially related to THC’s stimulation of ghrelin, a hormone that increases appetite but also increases the metabolism of carbohydrates. CBD on its own was shown in 2006 to lower the incidence of diabetes in lab rats, and in 2015 an Israeli-American biopharmaceutical collective began stage 2 trials related to using CBD to treat diabetes. Research has demonstrated that CBD helps the body convert white fat into weight-reducing brown fat, promoting normal insulin production and sugar metabolism.

In studying over 4,600 test subjects, researchers found that current cannabis users had fasting insulin levels that were up to 16 percent lower than their non-using counterparts, higher levels of HDL cholesterol that protects against diabetes, and 17 percent lower levels of insulin resistance. Respondents who had used cannabis in their lifetime but were not current users showed similar but less pronounced associations, indicating that the protective effect of cannabis fades with time.

Excess insulin promotes the conversion of sugars into stored fat and leads to weight gain and obesity. The research emerging about the interplay between cannabinoids and insulin regulation may lead to some major breakthroughs in the prevention of obesity and type 2 diabetes.

Better Cholesterol Profiles and Lowered Risk of Cardiovascular Disease

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Regular cannabis users had increased levels of HDL-C and slightly lower levels of LDL-C.

A 2013 study that measured data from 4,652 participants on the effect of cannabis on metabolic systems compared non-users to current and former users. It found that current users had higher blood levels of high-density lipoprotein (HDL-C) or “good cholesterol.” The same year, an analysis of over seven hundred members of Canada’s Inuit community found that, on average, regular cannabis users had increased levels of HDL-C and slightly lower levels of LDL-C (“bad cholesterol”).

Linked to diet and lifestyle, atherosclerosis is common in developed Western nations and can lead to heart disease or stroke. It is a chronic inflammatory disorder involving the progressive depositing of atherosclerotic plaques (immune cells carrying oxidized LDL or low-density lipoproteins). A growing body of evidence suggests that endocannabinoid signaling plays a critical role in the pathology of atherogenesis. The condition is now understood to be a physical response to injuries in the arterial walls’ lining, caused by high blood pressure, infectious microbes, or excessive presence of an amino acid called homocysteine. Studies have demonstrated that inflammatory molecules stimulate the cycle leading to atherosclerotic lesions. Existing treatments are moderately effective though carry numerous side effects. CB2 receptors triple in response to inflammation, allowing anandamide and 2-AG, the body’s natural cannabinoids, to decrease inflammatory responses. The CB2 receptor is also stimulated by plant-based cannabinoids.

A 2005 animal trial showed that low-dose oral cannabinoids slowed the progression of atherosclerosis. Researchers the following year wrote that the immunomodulatory capacity of cannabinoids was “well established” in science and suggested they had a broad therapeutic potential for a variety of conditions, including atherosclerosis.

A 2007 animal study with CBD showed it had a cardioprotective effect during heart attacks, and more details were published that year about the involvement of the CB1 and CB2 receptors in cardiovascular illness and health.

Reduced Risk of Cancer

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Several studies had already shown that THC prevents tumors and reduces them.

Could cannabidiol help prevent tumors and other cancers before they grow? A 2012 study showed that animals treated with CBD were significantly less likely to develop colon cancer after being induced with carcinogens in a laboratory. Several studies had already shown that THC prevents tumors and reduces them, including one in 1996 on animal models that found that it decreased the incidence of both benign and hepatic adenoma tumors. In 2015, scientists analyzed the medical records of over eighty-four thousand male patients in California and found that those who used cannabis, but not tobacco, had a rate of bladder cancer that was 45 percent below the norm. Topical products can be used to treat and prevent skin cancers. Continuing research is focused on the best ratio of CBD to THC and the most effective dose level in cancer prevention and treatment.

Cannabinoids Help Maintain Brain Health and Create Resilience to Trauma and Degeneration

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Cannabinoids help maintain and regulate brain health.

Cannabinoids are neuroprotective, meaning that they help maintain and regulate brain health. The effects appear to be related to several actions they have on the brain, including the removal of damaged cells and the improved efficiency of mitochondria. CBD and other antioxidant compounds in cannabis also work to reduce glutamate toxicity. Extra glutamate, which stimulates nerve cells in the brain to fire, causes cells to become over-stimulated, ultimately leading to cell damage or death. Thus, cannabinoids help protect brain cells from damage, keeping the organ healthy and functioning properly. CBD has also been shown to have an anti-inflammatory effect on the brain.

As the brain ages, the creation of new neurons slows down significantly. In order to maintain brain health and prevent degenerative diseases, new cells need to be continuously created. A 2008 study showed that low doses of CBD– and THC-like cannabinoids encouraged the creation of new nerve cells in animal models, even in aging brains. CBD also helps prevent other nerve-related diseases like neuropathy and Alzheimer’s disease.

Protects against Bone Disease and Broken Bones

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CBD helps spur the process of new bone-cell formation.

Cannabinoids are facilitative of the process of bone metabolism—the cycle in which old bone material is replaced by new at a rate of about 10 percent per year, crucial to maintaining strong, healthy bones over time. CBD in particular has been shown to block an enzyme that destroys bone-building compounds in the body, reducing the risk of age-related bone diseases like osteoporosis and osteoarthritis. In both of those diseases, the body is no longer creating new bone and cartilage cells. CBD helps spur the process of new bone-cell formation, which is why it has been found to speed the healing of broken bones and, due to a stronger fracture callus, decrease the likelihood of re-fracturing the bone (bones are 35–50 percent stronger than those of non-treated subjects).

Protects and Heals the Skin

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CBD can an repair damage from free radicals like UV rays and environmental pollutants.

The skin has the highest amount and concentration of CB2 receptors in the body. When applied topically as an infused lotion, serum, oil, or salve, the antioxidants in CBD (a more powerful antioxidant than vitamins E and C) can repair damage from free radicals like UV rays and environmental pollutants. Cannabinoid receptors can be found in the skin and seem to be connected to the regulation of oil production in the sebaceous glands. Cannabis-based topical products are being developed to treat related issues from acne to psoriasis and can promote faster healing of damaged skin. In fact, historical documents show that cannabis preparations have been used for wound healing in both animals and people in a range of cultures spanning the globe and going back thousands of years. The use of concentrated cannabis oils to treat skin cancer is gaining popularity with a number of well-documented cases of people curing both melanoma and carcinoma-type skin cancers with the topical application of CBD and THC products. Cannabis applied topically is not psychoactive.

Anti-inflammatory

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CBD is a known anti-inflamatory.

Cannabinoids have been proven to have an anti-inflammatory effect in numerous studies. CBD engages with the endocannabinoid system in many organs throughout the body, helping to reduce inflammation systemically. The therapeutic potential is impressively wide-ranging, as inflammation is involved in a broad spectrum of diseases.

This article has been adapted from CBD: A Patient’s Guide to Medicinal Cannabis by Leonard Leinow & Juliana Birnbaum (Berkeley, CA: North Atlantic Books, 2017).

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[Cannabis and lung. What we know and everything we don’t know yet].

Category : Antiinflamatorio

[Cannabis and lung. What we know and everything we don’t know yet].

Rev Pneumol Clin. 2017 Nov 07;:

Authors: Urban T, Hureaux J

Abstract
Cannabis use increased sharply from 2010 to 2014 in France. Cannabis is often consumed with tobacco, although the use of marijuana is developing. Tobacco and cannabis smoke have many common characteristics in terms of irritants, carcinogens and carbon monoxide. They also differentiate by their dependence mechanisms, with nicotine and its receptors for tobacco and tetra-hydro-cannabinol (THC) and its specific receptors for cannabis. Chronic inhalation (700,000 daily users in France) over a long period most likely increases the relative risk of bronchial cancer. But long-term cohort studies targeting this group of strong cannabis users, especially over time, are lacking. Inhalation of cannabis smoke, despite an acute bronchodilator effect, is associated with the risk of chronic bronchitis in the case of regular use. However, the risk of developing COPD in the exclusive marijuana smoker group with no associated tobacco is not yet clear, with studies yielding discordant results. There is also a lack of long-term follow-up studies of respiratory investigations in large cannabis users. Finally, cannabis smoke contains various cannabinoids, for example cannabidiol which also have anti-inflammatory and antifibrotic properties, with the unconfirmed hypothesis that these properties can partially modulate the deleterious action of cannabis smoke.

PMID: 29126755 [PubMed – as supplied by publisher]

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Cannabidiol as a treatment for epilepsy.

Category : Epilepsia

Cannabidiol as a treatment for epilepsy.

J Neurol. 2017 Nov 09;:

Authors: Pickrell WO, Robertson NP

PMID: 29124331 [PubMed – as supplied by publisher]

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Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology.

Category : Antiinflamatorio

Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology.

Clin Pharmacol Drug Dev. 2017 Nov 10;:

Authors: Atsmon J, Heffetz D, Deutsch L, Deutsch F, Sacks H

Abstract
Cannabidiol (CBD) is the main nonpsychoactive component of the cannabis plant. It has been associated with antiseizure, antioxidant, neuroprotective, anxiolytic, anti-inflammatory, antidepressant, and antipsychotic effects. PTL101 is an oral gelatin matrix pellets technology-based formulation containing highly purified CBD embedded in seamless gelatin matrix beadlets. Study objectives were to evaluate the safety and tolerability of PTL101 containing 10 and 100 mg CBD, following single administrations to healthy volunteers and to compare the pharmacokinetic profiles and relative bioavailability of CBD with Sativex oromucosal spray (the reference product) in a randomized, crossover study design. Administration of PTL101 containing 10 CBD, led to a 1.7-fold higher Cmax and 1.3-fold higher AUC compared with the oromucosal spray. Tmax following both modes of delivery was 3-3.5 hours postdosing. CBD exhibited about a 1-hour lag in absorption when delivered via PTL101. A 10-fold increase in the dose resulted in an ∼15-fold increase in Cmax and AUC. Bioavailability of CBD in the 10-mg PTL101 dose was 134% relative to the reference spray. PTL101 is a pharmaceutical-grade, user-friendly oral formulation that demonstrated safe and efficient delivery of CBD and therefore could be an attractive candidate for therapeutic indications.

PMID: 29125702 [PubMed – as supplied by publisher]

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Oral administration of cannabis with lipids leads to high levels of cannabinoids in the intestinal lymphatic system and prominent immunomodulation.

Category : Cancer

Related Articles

Oral administration of cannabis with lipids leads to high levels of cannabinoids in the intestinal lymphatic system and prominent immunomodulation.

Sci Rep. 2017 Nov 06;7(1):14542

Authors: Zgair A, Lee JB, Wong JCM, Taha DA, Aram J, Di Virgilio D, McArthur JW, Cheng YK, Hennig IM, Barrett DA, Fischer PM, Constantinescu CS, Gershkovich P

Abstract
Cannabidiol (CBD) and ∆(9)-tetrahydrocannabinol (THC) have well documented immunomodulatory effects in vitro, but not following oral administration in humans. Here we show that oral co-administration of cannabinoids with lipids can substantially increase their intestinal lymphatic transport in rats. CBD concentrations in the lymph were 250-fold higher than in plasma, while THC concentrations in the lymph were 100-fold higher than in plasma. Since cannabinoids are currently in clinical use for the treatment of spasticity in multiple sclerosis (MS) patients and to alleviate nausea and vomiting associated with chemotherapy in cancer patients, lymphocytes from those patients were used to assess the immunomodulatory effects of cannabinoids. The levels of cannabinoids recovered in the intestinal lymphatic system, but not in plasma, were substantially above the immunomodulatory threshold in murine and human lymphocytes. CBD showed higher immunosuppressive effects than THC. Moreover, immune cells from MS patients were more susceptible to the immunosuppressive effects of cannabinoids than those from healthy volunteers or cancer patients. Therefore, administering cannabinoids with a high-fat meal or in lipid-based formulations has the potential to be a therapeutic approach to improve the treatment of MS, or indeed other autoimmune disorders. However, intestinal lymphatic transport of cannabinoids in immunocompromised patients requires caution.

PMID: 29109461 [PubMed – in process]

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Efficacy and safety of cannabis for treating children with refractory epilepsy.

Category : Epilepsia

Related Articles

Efficacy and safety of cannabis for treating children with refractory epilepsy.

Nurs Child Young People. 2017 Sep 11;29(7):32-37

Authors: Neale M

Abstract
The aim of this literature review was to examine the evidence base for the safety and efficacy of cannabis in treating children with refractory epilepsy. Clinical and medical databases were searched and four articles were included in the final analysis, which included retrospective reviews and open-label trials with a total sample size of 424. One clinical trial included administration of cannabidiol, the non-psychoactive compound of cannabis, while the other three articles stated that the compound administered to participants contained tetrahydrocannabidiol, the psychoactive constituent of cannabis. Cannabis may reduce seizures in some children and young people with refractory epilepsy, however, its success may be affected by aetiology of the epilepsy or concomitant anti-epileptic drug use, and a therapeutic dose has not been found. Positive side effects were also found including improved sleep, alertness and mood. More research is needed on this subject, including randomised controlled trials. Nurses who are aware of patients and families wishing to trial cannabis for refractory epilepsy should have full and frank discussions.

PMID: 29115760 [PubMed – in process]

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From Clone to Concentrate: How CBD Cannabis Oil is Made

Category : Noticias

See how CBD cannabis oil is extracted and produced.
By Project CBD On November 08, 2017

How CBD cannabis oil is made

See how cannabis oil is extracted and produced.

Copyright, Project CBD. May not be reprinted without permission.

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Developmental effects of cannabidiol and Δ9-tetrahydrocannabinol in zebrafish.

Category : Epilepsia

Developmental effects of cannabidiol and Δ9-tetrahydrocannabinol in zebrafish.

Toxicol Sci. 2017 Nov 02;:

Authors: Carty DR, Thornton C, Gledhill J, Willett KL

Abstract
Cannabidiol (CBD) has gained much attention in the past several years for its therapeutic potential in the treatment of drug-resistant epilepsy, such as Dravet Syndrome. While CBD has shown anecdotal efficacy in reducing seizure frequency, little is known regarding the potential adverse side-effects of CBD on physiology, development, organogenesis, or behavior. The goal of this project is to compare the relative morphological, behavioral, and gene expression phenotypes resulting after a developmental exposure to Δ9-tetrahydrocannabinol (THC) or CBD. Zebrafish were exposed from blastula through larval stage (96 hour post fertilization) to 0.3, 0.6, 1.25, 2.5, 5 mg/L (1, 2, 4, 8, 16 μM) THC or 0.07, 0.1, 0.3, 0.6, 1.25 mg/L CBD (0.25, 0.5, 1, 2, 4 μM). Despite the similarity in THC and CBD dysmorphologies, i.e., edemas, curved axis, eye/snout/jaw/trunk/fin deformities, swim bladder distention, and behavioral abnormalities, the LC50 for CBD (0.53 mg/L) was nearly seven times lower than THC (3.65 mg/L). At 96 hpf, c-fos, dazl, and vasa were differentially expressed following THC exposure, but only c-fos expression was significantly increased by CBD. CBD was more bioconcentrated compared to THC despite higher THC water concentrations. This work supports the potential for persistent developmental impacts of cannabinoid exposure, but more studies are needed to assess latent effects and their molecular mechanisms of toxicity.

PMID: 29106691 [PubMed – as supplied by publisher]

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