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cannabidiol

  • by Paul Armentano, NORML Deputy Director September 25, 2014

    The administration of cannabidiol (CBD), a nonpsychotropic cannabinoid, is associated with improved quality of life in patients with Parkinson’s disease, according clinical trial data published online ahead of print in the Journal of Psychopharmacology.

    Investigators at the University of São Paulo in Brazil assessed the efficacy of CBD versus placebo in 21 subjects with Parkinson’s. Authors reported that the administration of 300 mg doses of CBD per day was associated with “significantly different mean total scores” in subjects’ well-being and quality of life compared to placebo.

    Separate assessments of CBD versus placebo reported that the cannabinoid did not appear to mitigate general symptoms of the disease, nor was it shown to be neuroprotective.

    “This study points to a possible effect of CBD in improving measures related to the quality of life of PD patients without psychiatric comorbidities,” investigators concluded. They added, “We found no statistically significant differences concerning the motor symptoms of PD; however, studies involving larger samples and with systematic assessment of specific symptoms of PD are necessary in order to provide stronger conclusions regarding the action of CBD in PD.”

    Clinical reports have previously indicated that both CBD and/or whole-plant cannabis may address various symptom’s of Parkinson’s disease, including improvement in motor symptoms, pain reduction, improved sleep, and a reduction in the severity of psychotic episodes.

    Survey data of patients with PD indicates that almost half of all subjects who try cannabis report experiencing subjective relief from the plant.

    The abstract of the study, “Effects of cannabidiol in the treatment of patients with Parkinson’s disease: An exploratory double-blind trial,” appears online here.

  • by Paul Armentano, NORML Deputy Director May 6, 2014

    Federal agencies are moving forward with plans to increase the US government’s production of research-grade cannabis.

    Last week, the US Drug Enforcement Administration (DEA) publicly announced in the Federal Register that it is increasing its marijuana production quota from 21 kilograms to 650 kilograms (about 1,443 pounds) in order to meet increasing demand for the plant from clinical investigators.

    Federal regulations permit a farm at the University of Mississippi to cultivate set quantities of cannabis for use in federally approved clinical trials. Regulators at the DEA, the US Food and Drug Administration, PHS (Public Health Service), and the US National Institute on Drug Abuse must approve any clinical protocol seeking to study the plant’s effects in human subjects.

    On various occasions, marijuana reform advocates and researchers have publicly criticized NIDA for failing to approve proposed trials seeking to assess the therapeutic benefits of cannabis. However, in March, federal regulators finally signed off on a long-delayed clinical protocol from researchers at the University of Arizona College of Medicine to evaluate the use of cannabis its in war veterans suffering from post-traumatic stress. Also this spring, lawmakers in several states, including Alabama, Kentucky, and Wisconsin, passed legislation encouraging state-sponsored clinical trials to assess the therapeutic potential of cannabidiol – a nonpsychotropic organic component of cannabis – in the treatment of intractable epilepsy.

    “The additional supply [of cannabis] to be manufactured in 2014 is designed to meet the current and anticipated research efforts involving marijuana,” A NIDA spokesperson told TheHill.com. “[T]his projection of increased demand is due in part to the recent increased interest in the possible therapeutic uses of marijuana.”

    According to a keyword search using the terms ‘smoked marijuana’ on the clinicaltrials.gov website, eight trials are presently ongoing to evaluate the plant’s effects in humans. Two of these trials are assessing the plant’s potential therapeutic efficacy.

  • by Paul Armentano, NORML Deputy Director April 10, 2014

    Lawmakers in Alabama and Utah recently approved legislation seeking to authorize the physician-supervised use of varieties of cannabis and/or extracts high in the non-psychotropic cannabinoid cannabidiol (CBD). Both measures, which I previously summarized as ‘largely unworkable,‘ have now been signed into law.

    In recent days, lawmakers in three additional states — Kentucky, Mississippi, and Wisconsin — have similarly signed off on CBD-explicit legislation. These measures are now awaiting signatures from each states’ respective Governors.

    Similar to Alabama’s SB 174 (aka ‘Carley’s Law), which only permits the use of CBD by prescription during the course of an FDA-approved clinical trial, the pending Kentucky and Wisconsin bills may also be classified as ‘research-centric’ measures. Kentucky’s SB 124 permits physicians “practicing at a hospital or associated clinic affiliated with a Kentucky public university” to “dispense” cannabidiol during the course of an FDA-approved clinical trial. Wisconsin’s AB 726 similarly limits those who may legally dispense CBD to only include those physicians who have obtained an FDA-issued investigational drug permit to prescribe it. In Tennessee, lawmakers are also close to finalizing similar language (included in HB 2461 and SB 2531) that seeks to allow university clinical researchers to “manufacture” and “dispense” high-CBD cannabis oil “as part of a clinical research study on the treatment of intractable seizures.” (By contrast, separate, broader medical cannabis measures seeking to authorize the use of the whole plant failed this year in all three states.)

    As I’ve previously written here and here, it is unlikely that specific changes in state law will stimulate these type of proposed clinical trials from taking place in these states any time soon. Because CBD is acknowledged by federal regulators to be classified as a schedule I prohibited substance, multiple federal agencies — including the FDA, DEA, NIDA (US National Institute of Drug Abuse), and PHS (Public Health Service) must all sign off on any clinical investigation of the cannabinoid — a process that typically takes several years. A keyword search of FDA-approved clinical trials using the terms “cannabidiol” and “United States” yields fewer than ten ongoing human trials involving CBD — less than half of which are assessing its potential therapeutic application. (Two additional safety trials assessing the use of GW Pharmaceutical’s patented high-CBD formulation Epidiolex in children with severe epilepsy are also ongoing.)

    Unlike the above-mentioned measures, Mississippi’s HB 1231, does not seek to encourage state-sponsored clinical trials. Rather, the measure exempts specific high-CBD formulated oils “that contain more than fifteen percent cannabidiol [and] … no more than one-half of one percent of tetrahydrocannabinol” from the state’s definition of a schedule I prohibited substance. However, like Utah’s HB 105 (aka ‘Charlee’s Law), Mississippi’s pending law does not provide guidance as to where patients could legally obtain such extracts. Though such high-CBD products are presently available in a limited number of medical cannabis states (such as in California and Colorado), these extracts are typically only available to in-state residents who possess authorization from a physician licensed to practice in that state. (Although Colorado state law also allows for a recreational cannabis market, which may be legally accessed by out-of-state residents, at present time such high-CBD concentrates are seldom available at retail outlets.)

    Additional cannabidiol-specific measures also remain pending in Florida and South Carolina, among other states. NORML will report on these measures as they progress and we will continue to express caution in regards to their practical utility for those patients who require immediate access to whole-plant cannabis and its variety of naturally-occurring compounds.

  • by Paul Armentano, NORML Deputy Director March 25, 2014

    At a public signing ceremony today, Utah’s Republican Gov. Gary Herbert will approve House Bill 105 — aka “Charlee’s Law.” The law, and others like it, ostensibly allows children with treatment-resistant pediatric epilepsy access to extracts of the marijuana plant high in the cannabinoid cannabidiol (CBD).

    While some media outlets are reporting that the passage of these measures are akin to ‘approving medical marijuana,’ such claims are far from accurate.

    Specifically, Utah’s HB 105 — which takes effect on July 1 — is largely unworkable. As written, the law only exempts from state prosecution those with “intractable epilepsy” who possess a cannabis extract that contains more than 15 percent CBD and no more than 0.3 percent THC. Patients must receive a written recommendation from a Utah board certified neurologist and be registered with the state Department of Health before seeking such extracts, which for the time being may only be procured from outside of the state. The extracts must be produced in a lab that possess a state-license to manufacture such products.

    While this language may appear to allow Utah patients to procure CBD products in neighboring medical cannabis states like Colorado, the likelihood of this scenario is highly doubtful. Colorado’s medical marijuana law only allows those who are state residents and who possess a state-issued patient identification card to legally purchase such products. In other words, Utah parents would have to violate Colorado law to obtain high-CBD extracts (which are likely to only be available from a medical dispensary, not a retail cannabis market). Colorado medical marijuana dispensaries would also be in violation of not just the letter of the law, but also the spirit of the law by providing a product they know is intended to be transported across state lines — a clear violation of the guidelines put forward in the August 2013 Department of Justice memo which call for “preventing the diversion of marijuana from states where it is legal in some form to other states.”

    Utah’s forthcoming law also calls on the state Department of Agriculture “to grow or cultivate industrial hemp for the purpose of
    agricultural or academic research,” ostensibly for the purpose of one-day producing high-CBD cannabis medicines. However, it remains to be seen whether such industrial crops can yield therapeutically effective CBD extracts or whether federal lawmakers would even allow such a state-sponsored research project to move forward.

    In Alabama, members of the House and Senate unanimously approved CBD-specific legislation, Senate Bill 174 aka “Carley’s Laws,” late last week. Republican Gov. Robert Bently has announced his intent to sign the measure into law.

    However, like the Utah law, Alabama’s forthcoming law will also be largely unworkable for those who seek to benefit from it. The measure appropriates $1 million dollars for University of Alabama-sponsored research in CBD extracts. Whether such research will actually take place is another story. Because CBD is, like the cannabis plant itself, classified under federal law as a schedule I controlled substance, multiple federal agencies — including the FDA, DEA, NIDA (US National Institute of Drug Abuse), and PHS (Public Health Service) must all sign off on any clinical investigation of the drug — a process that typically takes several years and often ends with federal regulators rejecting the protocol outright. Yet, under “Carley’s Law,” patients may only legally access CBD under if it is “prescribed” during the course of such a federally approved clinical trial.

    Nevertheless, despite these obvious limitations in implementation, lawmakers in various other states — including Florida, Kentucky, Minnesota, South Carolina, and Wisconsin — are considering passing similar measures. (A similar Georgia measure died when lawmakers adjourned late last week.) While the passage of these measures may pose symbolic victories for legislators, they fail to provide tangible benefits to the constituents that they are intended to serve.

  • by Paul Armentano, NORML Deputy Director March 19, 2014

    Lawmakers in four states — Alabama, Georgia, Kentucky, and Utah — are poised to enact legislation in the coming days/weeks aimed at providing patients, primarily children with forms of intractable epilepsy, with strains of cannabis and/or cannabis extracts high in the compound cannabidiol (CBD).

    I have previously written why, in theory, these proposals will likely provide only limited relief for patients. A closer look at the text of these proposed laws indicates that, in fact, they are largely unworkable and will most likely provide no tangible relief or protection for the patient community they are intended to serve.

    Excerpt via Alternet.org. (Read the entire article here.)

    Alabama: Senate lawmakers unanimously approved SB 174, aka “Carley’s Law,” which seeks to allow investigators at the University of Alabama to study CBD in FDA-approved trials. But no change in state law is actually necessary to permit state university researchers to conduct clinical trials on cannabidiol. Such FDA-approved protocols are already permitted under federal law, but they require the added approval of regulators at the DEA, NIDA (National Institute on Drug Abuse), and PHS (Public Health Service). However, since CBD (like marijuana) is classified as a Schedule I substance under federal law, these agencies have historically been reticent to allow such studies to go forward, a fact that will likely remain unchanged even if House members similarly sign off on Carley’s Law.

    Georgia: A Senate panel last week amended and approved House Bill 885, aka “Haley’s Hope Act.” …The amended Senate plan … only provides for an exemption from state prosecution for those who obtain CBD oil from a legal medical marijuana state and transport it back to Georgia. In theory, this would allow Georgia parents to visit a state like Colorado to obtain medicine for their children. But in practice, Colorado’s medical marijuana law only allows those who are state residents and who possess a state-issued patient identification card to legally purchase such products. In other words, Georgia parents would have to violate Colorado law to obtain CBD-oils (which are likely to only be available from a medical dispensary, not a retail cannabis market). Colorado medical marijuana dispensaries would also be in violation of not just the letter of the law, but also the spirit of the law by providing a product they know is intended to be transported across state lines—a clear violation of the guidelines put forward in the August 2013 Department of Justice memo which call for “preventing the diversion of marijuana from states where it is legal in some form to other states.”

    Kentucky: Senators last week gave unanimous approval to Senate Bill 124. Like Alabama’s proposal, the bill calls on University of Kentucky researchers to study CBD in clinical trials — something they could do with or without passage of a new state law, if the necessary federal agencies agreed to it. The measure also seeks to allow physicians at state teaching hospitals to recommend CBD to patients. However, past experience from other states indicates that this latter scenario is unlikely. In 2013, Maryland lawmakers enacted legislation to allow physicians at the state’s limited number of teaching hospitals to dispense cannabis. To date, no Maryland hospitals have taken up the state’s invitation to do so.

    Utah: House and Senate lawmakers have given final approval to House Bill 105. Utah’s governor is expected to sign the measure into law imminently. Like Georgia’s proposal, the Utah measure, which sunsets in 2016, provides protection from state prosecution for parents who can acquire CBD-oil for their epileptic children, assuming a neurologist has authorized the treatment. But, as will be the case in Georgia, Utah patients will likely only be able to obtain CBD from out of state, an act that would violate neighboring states’ medical cannabis laws. The Utah proposal also calls on the state Department of Agriculture to grow industrial hemp for the purposes of one day producing cannabis medicines. However, it remains to be seen whether such industrial crops can yield therapeutically effective CBD-extracts or whether federal lawmakers would even allow such a state-sponsored research project to move forward.

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