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clinical trials

  • by Paul Armentano, NORML Deputy Director June 4, 2017

    Marijuana researchScientists have conducted over 140 controlled clinical trials since 1975 assessing the safety and efficacy of whole-plant cannabis or specific cannabinoids, according to a new literature review published in the journal Critical Reviews in Plant Sciences.

    A pair of German researchers identified 140 clinical trials involving an estimated 8,000 participants. Of these, the largest body of literature focused on the use of cannabis or cannabinoids in the treatment of chronic or neuropathic pain. Authors identified 35 controlled studies, involving 2,046 subjects, assessing the use of marijuana or cannabinoids in pain management. In January, the National Academy of Sciences acknowledged that “conclusive or substantial evidence” exists for cannabis’ efficacy in patients suffering from chronic pain.

    Cannabinoids have also been well studied as anti-emetic agents and as appetite stimulants. Researchers identified 43 trials evaluating marijuana or its components for these purposes, involving total 2,498 patients. They also identified an additional 14 trials examining the role of cannabis or cannabis-derived extracts in the treatment of multiple sclerosis.

    Researchers also identified several additional trials evaluating the use of cannabis or cannabinoids for Crohn’s disease, Tourette’s syndrome, Parkinson’s disease, glaucoma, epilepsy, and various other indications.

    A 2014 study published in the Journal of the American Medical Association reported that new drugs typically gain FDA approval on the basis of one or two pivotal clinical trials.

    Full text of the study, “Medicinal uses of marijuana and cannabinoids,” appears online here.

  • by Paul Armentano, NORML Deputy Director February 22, 2016

    for_painThe long-term, daily use of cannabis is associated with improved analgesia and reduced opioid use in patients with treatment-resistant chronic pain conditions, according to clinical trial data reported online ahead of print in The Clinical Journal of Pain.

    Investigators with Hebrew University in Israel evaluated the use of cannabis on pain in a cohort of 176 patients, each of whom had been previously unresponsive to all conventional pain medications. Subjects inhaled THC-dominant cannabis daily (up to 20 grams per month) for a period of at least six months.

    A majority of participants (66 percent) experienced improvement in their pain symptom scores after cannabis therapy, and most reported “robust” improvements in their quality of life. Subjects’ overall consumption of opioid drugs declined 44 percent by the end of the trial, and a significant percentage of participants discontinued opioid therapy altogether over the course of the study.

    Authors concluded, “In summary, this long-term prospective cohort suggests that cannabis treatment in a mixed group of patients with treatment-resistant chronic pain may result in improved pain, sleep and quality of life outcomes, as well as reduced opioid use.”

    The Israeli results are similar to those reported in a 2015 Canadian trial which concluded that chronic pain patients who use herbal cannabis daily for one-year experienced reduced discomfort and increased quality of life compared to controls, and did not possess an increased risk of serious side effects.

    According to data published in 2014 in The Journal of the American Medical Association, US states with medical marijuana laws experience far fewer opiate-related deaths than do states that prohibit the plant. Investigators from the RAND Corporation and the University of California, Irvine reported similar findings in 2015, concluding, “States permitting medical marijuana dispensaries experience a relative decrease in both opioid addictions and opioid overdose deaths compared to states that do not.” Clinical data published in 2011 in the journal Clinical Pharmacology & Therapeutics previously reported that the administration of vaporized cannabis “safely augments the analgesic effect of opioids.”

    A review published earlier this year in the Canadian Journal of Anesthesia assessing the clinical use of cannabinoids for pain in over 1,300 subjects concludes, “Overall, the recent literature supports the idea that currently available cannabinoids are modestly effective analgesics that provide a safe, reasonable therapeutic option for managing chronic non-cancer-related pain and possibly cancer-related pain.”

    An abstract of the study, “The effect of medicinal cannabis on pain and quality of life outcomes in chronic pain: A prospective open-label study,” appears online here.

  • by Paul Armentano, NORML Deputy Director November 17, 2015

    pain_reliefCannabinoids are safe and effective for the treatment of chronic pain, according to the results of a systematic review of randomized controlled trials published in the Journal of Neuroimmune Pharmacology.

    Investigators from Dalhousie University in Halifax, Nova Scotia and McGill University in Montreal evaluated the results of 11 placebo-controlled trials conducted between the years 2010 and 2014. Trials assessed the use of various types of cannabinoid preparations, including herbal cannabis, liquid and oral cannabis extracts, and nabilone (a synthetic analog of THC), in pain treatment.

    Cannabinoids possessed “significant analgesic effects” and were “well tolerated” in the majority of studies reviewed.

    Authors concluded, “The current systematic review provides further support that cannabinoids are safe, demonstrate a modest analgesic effect and provide a reasonable treatment option for treatment chronic non-cancer pain.”

    A 2011 review of 18 separate randomized trials evaluating the safety and efficacy of cannabinoids for pain management similarly reported, “[C]annabinoids are a modestly effective and safe treatment option for chronic non-cancer (predominantly neuropathic) pain.”

    In September, Canadian researchers reported that pain patients who consumed herbal cannabis daily for one-year experienced decreased analgesia and no increase in serious adverse side effects compared to matched controls.

    An abstract of the study, “Cannabinoids for the treatment of chronic non-cancer pain: An updated systematic review of randomized controlled trials,” appears online here.

  • by Paul Armentano, NORML Deputy Director June 23, 2015

    Cannabis ResearchSeveral mainstream media outlets are reporting that the US Department of Health and Human Services has removed a requirement mandating that all investigative protocols seeking cannabis for clinical study must undergo a Public Health Service review. The review process, which was enacted in 1999 and applied only to clinical studies involving cannabis, was long criticized by advocates as unnecessarily burdensome and time-consuming.

    Commenting on the change, a Health and Human Services spokeswoman said, “The department expects the action announced today will help facilitate further research to advance our understanding about the health risks and any potential benefits of medications using marijuana or its components or derivatives.”

    But as I point out in today’s news wire coverage here, such claims are likely overstated.

    That is because unique hurdles to clinical cannabis research will continue to exist as long as the plant is a) classified as a schedule I controlled substance defined as possessing no medical use and b) the source material for clinical trials must be provided by the US government’s lone supplier, the University of Mississippi (which is overseen by the US National Institute on Drug Abuse).

    Further, despite this announced change, the DEA and NIDA (along with the FDA) still must oversee all clinical marijuana research. One of these agencies (the DEA) is in place to enforce the federal criminal prohibition of marijuana. The other agency (NIDA) exists largely as an outgrowth of marijuana’s schedule I status. It remains highly unlikely that the very agencies in place to oversee and preserve cannabis prohibition would ever permit the type of rational review that would ultimately lead policymakers and the public to question the status quo.

    Finally, it bears repeating that ample scientific research already exists to contradict cannabis’ federal, schedule I status as a substance without medical utility, lacking acceptable safety, and possessing a high potential of abuse. More clinical research is welcome, but unfortunately science has never driven marijuana policy. If it did, the United States would already have a very different policy in place.

  • by Paul Armentano, NORML Deputy Director August 18, 2014

    The administration of a single dose of whole-plant cannabis via a thermal-metered inhaler is effective and well tolerated among patients suffering from neuropathy (nerve pain), according to clinical trial data published online ahead of print in the Journal of Pain and Palliative Care Pharmacotherapy.  

    Israeli investigators assessed the efficacy of a novel, portable metered-dose cannabis inhaler in eight subjects diagnosed with chronic neuropathic pain. Researchers reported that the device administered an efficient, consistent, and therapeutically effective dosage of cannabinoids to all participants.

    They concluded, “This trial suggests the potential use of the Syqe Inhaler device as a smokeless delivery system of medicinal cannabis, producing a delta-9-THC pharmacokinetic profile with low inter-individual variation of (maximum drug/plasma concentrations), achieving pharmaceutical standards for inhaled drugs.”

    A series of clinical trials conducted by investigators affiliated with the Center for Medicinal Cannabis Research at the University of California, San Diego previously determined that the inhalation of whole-plant cannabis is efficacious in the treatment of neuropathic pain.

    Full text of the study, “The pharmacokinetics, efficacy, safety, and ease of use of a novel portable metered-dose cannabis inhaler in patients with chronic neuropathic pain: A phase 1a study,” will appear in the Journal of Pain and Palliative Care Pharmacotherapy.

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