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cannabidiol

  • by Paul Armentano, NORML Deputy Director January 26, 2015

    American Academy of Pediatrics Calls For Rescheduling CannabisAn updated policy statement issued today by the American Academy of Pediatrics (AAP) calls for the rescheduling of the cannabis plant under federal law to better facilitate clinical trial research and to promote the plant’s eventual pharmaceutical development.

    The new position statement resolves: “The AAP strongly supports research and development of pharmaceutical cannabinoids and supports a review of policies promoting research on the medical use of these compounds. The AAP recommends changing marijuana from a Drug Enforcement Administration schedule I (controlled substance) to a Schedule II drug to facilitate this (clinical) research.”

    By definition, schedule I controlled substances are defined as possessing no “accepted medical use.” Clinical protocols involving cannabis are strictly controlled and require authorization from various federal agencies, including DEA, FDA, and the National Institute on Drug Abuse (NIDA) – the latter of which is designated under federal law as the sole provider of cannabis and/or organic cannabinoids for research purposes.

    “A Schedule 1 listing means there’s no medical use or helpful indications, but we know that’s not true because there has been limited evidence showing [marijuana] may be helpful for certain conditions in adults,” said Dr. Seth Ammerman, who co-authored the new policy statement.

    The newly amended AAP resolution also acknowledges that certain types of cannabinoid-therapy may provide benefits to adolescents, particularly those patient populations with treatment-resistant forms of epilepsy and chronic seizures. It states, “The AAP recognizes that marijuana may currently be an option for cannabinoid administration for children with life-limiting or severely debilitating conditions and for whom current therapies are inadequate.”

    Last year the Epilepsy Foundation of America issued a similar resolution, citing preclinical data and observational reports of the potential therapeutic benefit of the cannabinoid cannabidiol (CBD) in pediatric patients and calling for “an end to Drug Enforcement Administration (DEA) restrictions that limit clinical trials and research into medical marijuana for epilepsy.”

    Separate language in the AAP’s position statement also addresses the social use of the plant, affirming, “AAP strongly supports the decriminalization of marijuana use for both minors and young adults and encourages pediatricians to advocate for laws that prevent harsh criminal penalties for possession or use of marijuana.” By contrast, the statement acknowledges the group’s continued opposition to the legalization of marijuana, a policy change that it alleges poses “potential harm to children.”

    Text of the amended AAP position paper is online here. A summary of resolutions issued by other medical and health organizations in regard to patient access to therapeutic cannabis is available on the NORML website here.

  • by Paul Armentano, NORML Deputy Director November 26, 2014

    State Public Health Department officials have recommended over $7 million dollars in grant funding to pay for a series of state-sponsored clinical trials to assess the safety and efficacy of cannabis and cannabinoids.

    The proposed studies include a pair of clinical trials to evaluate the use of cannabidiol (CBD), a nonpsychotropic plant cannabinoid, for patients with pediatric epilepsy. Two additional trials will assess the use of cannabis for patients suffering from post-traumatic stress. Other studies will assess the efficacy of either cannabis or CBD in the treatment of Parkinson’s disease, brain tumors, ulcerative colitis, and pain management. (More specific summaries of all eight proposed studies are available online here.)

    Grant funding for the proposed studies requires final approval by the state Board of Health in December.

    Following funding approval, researchers will still be required to gain additional federal approval in order to obtain access to research-grade cannabis or CBD.

    The state of California previously sponsored a similar series of clinical trials assessing the safety and efficacy of marijuana. Those studies evaluated the use of whole-plant cannabis in patients with neuropathy, multiple sclerosis, and autoimmune deficiencies. A summary of those trials, published in 2012, concluded, “Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.”

  • by Paul Armentano, NORML Deputy Director October 13, 2014

    Israeli investigators intend to evaluate the potential anti-tumoral effects of the canabinoid cannabidiol (CBD) in select cancer patients.

    Researchers at the Hassadah Medical Center in Jerusalem will conduct a Phase II clinical trial to assess the impact of CBD as single treatment in cancer patients who have failed to respond to conventional therapies. Participants in the trial will receive CBD therapy for a period of eight weeks.

    Data documenting the potent anti-cancer activity of various cannabinoids – including THC, CBD, and CBG – both in culture and in animals dates back to the mid-1970s. To date, however, virtually no clinical trials exist reproducing these results in human subjects.

    In August, pharmaceutical provider Insys Therapeutics announced that it had received orphan drug status for its proprietary formulation of CBD for the treatment of glioblastoma, a hard-to-treat, aggressive form of brain cancer.

    Organic CBD remains classified under federal law as a schedule I controlled substance.

    Further details of the forthcoming Israeli trial are available online from the clinicaltrials.gov website here. Patient recruitment has yet to begin for this study.

  • 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.

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