Investigators at the University of California, Davis Medical Center conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in 39 subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Subjects inhaled cannabis of either moderate THC (3.53 percent), low dose THC (1.29 percent), or zero THC (placebo). Subjects continued to take all other concurrent medications as per their normal routine during the 3- to 4-week study period. Spontaneous pain relief, the primary outcome variable, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).
Researchers reported: “Both the low and medium doses proved to be salutary analgesics for the heterogeneous collection of neuropathic pain conditions studied. Both active study medications provided statistically significant 30% reductions in pain intensity when compared to placebo.”
They concluded: “Both the 1.29% and 3.53% vaporized THC study medications produced equal antinociception at every time point. … [T]he use of low doses could potentially be prescribed by physicians interested in helping patients use cannabis effectively while minimizing cognitive and psychological side effects. Viewed with this in mind, the present study adds to a growing body of literature supporting the use of cannabis for the treatment of neuropathic pain. It provides additional evidence of the efficacy of vaporized cannabis as well as establishes low-dose cannabis (1.29%) as having a favorable risk-benefit ratio.”
Previous clinical trials have indicated that inhaled cannabis can safety and effectively relieve various types of pain, particularly neuropathy — a hard-to-treat nerve condition often associated with cancer, HIV, spinal cord injury, diabetes, multiple sclerosis, and other conditions. These include the following double-blind, placebo-controlled (FDA gold-standard) studies:
Ware et al. 2010. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ 182: 694-701.
Wilsey et al. 2008. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. Journal of Pain 9: 506-521.
Ellis et al. 2008. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology 34: 672-80.
Abrams et al. 2007. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology 68: 515-521.
Wallace et al. 2007. Dose-dependent Effects of Smoked Cannabis on Capsaicin-induced Pain and Hyperalgesia in Healthy Volunteers Anesthesiology 107: 785-796.
Separate clinical trial data also reports that inhaled “cannabis augments the analgesic effect of opioids” and therefore “may allow for opioid treatment at lower doses with fewer side effects.”
Since 1999, US sales of opiate drugs have tripled in number and in 2010, a record-setting 254 million prescriptions for opioids were filled in the United States — enough to medicate every American adult around the clock for a month. (In particular, the manufacturing of the drug Oxycodone has increased from 8.3 tons in 1997 to 105 tons in 2011, an increase of 1,200 percent.) Overdose deaths from the use of prescription painkillers are also now at record levels, totaling some 15,000 annually — more than triple the total a decade ago.
Full text of the study, “Low-dose vaporized cannabis significantly improves neuropathic pain,” appears in The Journal of Pain.
Three quarters of medical cannabis consumers report using it as a substitute for prescription drugs, alcohol, or some other illicit substance, according to survey data published in the journal Addiction Research and Theory.
An international team of investigators from Canada and the United States assessed the subjective impact of marijuana on the use of licit and illicit substances via self-report in a cohort of 404 medical cannabis patients recruited from four dispensaries in British Columbia, Canada.
Researchers reported that subjects frequently substituted cannabis for other substances, including conventional pharmaceuticals. Authors reported:
“Over 41 percent state that they use cannabis as a substitute for alcohol (n=158), 36.1 percent use cannabis as a substitute for illicit substances (n=137), and 67.8 percent use cannabis as a substitute for prescription drugs (n=259). The three main reasons cited for cannabis-related substitution are ‘less withdrawal’ (67.7 percent), ‘fewer side-effects’ (60.4 percent), and ‘better symptom management’ suggesting that many patients may have already identified cannabis as an effective and potentially safer adjunct or alternative to their prescription drug regimen.”
Overall, 75.5 percent (n=305) of respondents said that they substitute cannabis for at least one other substance. Men were more likely than women to report substituting cannabis for alcohol or illicit drugs.
Authors concluded: “While some studies have found that a small percentage of the general population that uses cannabis may develop a dependence on this substance, a growing body of research on cannabis-related substitution suggests that for many patients cannabis is not only an effective medicine, but also a potential exit drug to problematic substance use. Given the credible biological, social and psychological mechanisms behind these results, and the associated potential to decrease personal suffering and the personal and social costs associated with addiction, further research appears to be justified on both economic and ethical grounds. Clinical trials with those who have had poor outcomes with conventional psychological or pharmacological addiction therapies could be a good starting point to further our under- standing of cannabis-based substitution effect.”
Previous studies have similarly demonstrated cannabis’ potential efficacy as an exit drug. A 2010 study published in the Harm Reduction Journal reported that cannabis-using adults enrolled in substance abuse treatment programs fared equally or better than nonusers in various outcome categories, including treatment completion. A 2009 study reported that 40 percent of subjects attending a California medical cannabis dispensary reported using marijuana as a substitute for alcohol, and 26 percent used it to replace their former use of more potent illegal drugs. A separate 2009 study published in the American Journal on Addictions reported that moderate cannabis use and improved retention in naltrexone treatment among opiate-dependent subjects in a New York state inpatient detoxification program.
Full text of the study, “Cannabis as a substitute for alcohol and other drugs: A dispensary-based survey of substitution effect in Canadian medical cannabis patients,” appears online in Addiction Research and Theory. NORML Advisory Board Member Mitch Earleywine is a co-author of this study.
Arizona Superior Court Judge: State-Licensed Dispensing Of Medical Cannabis Is Not Preempted By Federal LawDecember 18, 2012
A 2010 voter-approved Arizona state law authorizing “the local cultivation, sale, and use, of medical marijuana” is not preempted by the federal Controlled Substances Act, according to the Superior Court of Arizona, Maricopa County.
The ruling, issued earlier this month by Superior Court Judge Michael Gordon, allows for the establishment of state-licensed medicinal cannabis dispensaries within Arizona — the first of which opened its doors last week. State-licensed medical marijuana facilities now operate in several states, including Colorado, New Jersey, New Mexico, and Maine.
A majority of Arizona voters approved the AMMA in 2010. Under the law, qualified patients may possess and, depending on where they reside, cultivate cannabis. The program also mandates the state to license citizens to form not-for-profit dispensaries to grow and dispense cannabis. AMMA requires that each of the state’s 126 Community Health Care Analysis Areas permit at least one dispensary operator. Maricopa County’s prosecutor sought to block the establishment of local dispensaries by claiming that AMMA was preempted by federal anti-drug laws.
Writing for the Court in White Mountain Health Center, Inc. v. Maricopa County, Judge Gordon declared that nothing in the Arizona Medical Marijuana Act circumvents federal law since Justice Department officials, if they wished to do so, could still continue to locally enforce the Controlled Substances Act. “No one can argue that the federal government’s ability to enforce the CSA is impaired to the slightest degree [by Arizona’s medical marijuana law],” Gordon opined, adding that the new law “affirmatively provides a roadmap for federal enforcement of the CSA, if they so wished to” since the statute requires patients and proprietors to register their activities with the state.
Judge Gordon further suggested that Arizona’s law did not conflict with the federal lawmakers’ intentions when they enacted the federal Controlled Substances Act. He declared, “Instead of frustrating the CSA’s purpose, it is sensible to argue that the AMMA furthers the CSA’s objectives in combating drug abuse and the illegitimate trafficking of controlled substances.”
He concluded: “The Court rejects … arguments that the [law] violates public policy simply because marijuana use and possession violate federal law. Eighteen states and the District of Columbia have passed legislation permitting the use of marijuana in whole or in part. The Court will not rule that Arizona, having sided with the ever-growing minority of States, and having limited it to medical use, has violated public policy.”
Maricopa County Attorney Bill Montgomery is appealing Judge Gordon’s ruling.
Arizona regulations regarding patient access and dispensary operations is available from the Arizona Department of Health Services here.
Scientific Review: “There Is Now Clear Evidence That Cannabinoids Are Useful For The Treatment Of Various Medical Conditions”August 9, 2012
For the second time in recent months, a scientific paper published in a peer-reviewed journal has thoroughly rebutted the present Schedule I status of cannabis under US federal law, which states that the plant and its organic constituents possess a “high potential for abuse,” and that they lack “accepted medical use” and “accepted safety … under medical supervision.”
According to a just published review in the German scientific journal Deutsches Ärzteblatt International, scientific findings from over 100 controlled clinical trials involving either cannabis or its constituents provide “clear evidence that cannabinoids are useful for the treatment of various medical conditions.”
Investigators from the nova-Institute and the Hannover Medical School in Germany reviewed over 100 controlled trials assessing the safety and efficacy of cannabis and cannabinoids.
Researchers reported: “Knowledge about the therapeutic potential of cannabis products has been greatly improved by a large number of clinical trials in recent years. … There is now clear evidence that cannabinoids are useful for the treatment of various medical conditions,” including chronic neuropathy (nerve pain), multiple sclerosis, HIV/AIDS, Gilles de la Tourette syndrome, and other indications.
Regarding the safety profile of cannabis and cannabinoids, investigators determined: “The most common side effects of cannabinoids are tiredness and dizziness (in more than ten percent of patients), psychological effects, and dry mouth. Tolerance to these side effects nearly always develops within a short time. Withdrawal symptoms are hardly ever a problem in the therapeutic setting.”
Authors did express concern that cannabis could pose additional health risks for adolescents and/or pregnant or breast-feeding women, as well as individuals diagnosed with Hepatitis C, severe cardiovascular disease, addictive disorders, or those vulnerable to certain psychiatric disorders, such as schizophrenia.
Investigators acknowledged that cannabis dosing may adversely impact psychomotor skills. However, they noted, “Patients who take cannabinoids at a constant dosage over an extensive period of time often develop tolerance to the impairment of psychomotor performance, so that they can drive vehicles safely.”
They concluded, “No acute deaths have been described that could be unequivocally attributed solely to cannabis consumption or treatment with cannabinoids.”
This most recent paper follows the publication of a similar review, published in May in The Open Neurology Journal. In that paper, investigators with the University of California at San Diego and the University of California, Davis concluded: “Evidence is accumulating that cannabinoids may be useful medicine for certain indications. Based on evidence currently available, the (federal) Schedule I classification (of cannabis) is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.”
In 2011, the Obama administration — via the United States Drug Enforcement Administration (DEA) — formally denied a nine-year-old administrative petition filed by NORML and a coalition of public interest organizations calling on the agency to initiate hearings to reassess the present classification of marijuana as a schedule I controlled substance. In her denial of the petition, DEA administrator Michele Leonhart alleged: “[T]here are no adequate and well-controlled studies proving (marijuana’s) efficacy; the drug is not accepted by qualified experts. … At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”
Coalition advocates are presently appealing the DEA’s denial of their petition in federal court.
Full text of the most recent study, “The therapeutic potential of cannabinoids,” is available online here.
The present classification of cannabis and its organic compounds as schedule I prohibited substances under federal law is scientifically indefensible, according to a just published review in The Open Neurology Journal.
Investigators with the University of California at San Diego and the University of California, Davis reviewed the results of several recent clinical trials assessing the safety and efficacy of inhaled or vaporized cannabis. They concluded:
“Evidence is accumulating that cannabinoids may be useful medicine for certain indications. Control of nausea and vomiting and the promotion of weight gain in chronic inanition are already licensed uses of oral THC (dronabinol capsules). Recent research indicates that cannabis may also be effective in the treatment of painful peripheral neuropathy and muscle spasticity from conditions such as multiple sclerosis. Other indications have been proposed, but adequate clinical trials have not been conducted.
“… The classification of marijuana as a Schedule I drug as well as the continuing controversy as to whether or not cannabis is of medical value are obstacles to medical progress in this area. 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. It is true cannabis has some abuse potential, but its profile more closely resembles drugs in Schedule III (where codeine and dronabinol are listed). The continuing conflict between scientific evidence and political ideology will hopefully be reconciled in a judicious manner.”
The lead author of the review, Dr. Igor Grant, is the director of the Center for Medicinal Cannabis Research. In recent years, the CMCR has conducted various FDA-approved ‘gold standard’ clinical trials evaluating inhaled cannabis as a therapeutic agent. The results of several of those trials are summarized here.
Under federal law, schedule I controlled substances are defined as possessing “a high potential for abuse, … no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision.” Heroin and Methaqualone (Quaaludes) are examples of other Schedule I substances.
In 2011, the Obama administration — via the United States Drug Enforcement Administration (DEA) — formally denied a nine-year-old administrative petition filed by NORML and a coalition of public interest organizations calling on the agency to initiate hearings to reassess the present classification of marijuana as a schedule I controlled substance without any ‘accepted medical use in treatment.’ In her denial of the petition, DEA administrator Michele Leonhart alleged: “[T]here are no adequate and well-controlled studies proving (marijuana’s) efficacy; the drug is not accepted by qualified experts. … At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”
Coalition advocates are presently appealing the DEA’s denial of their petition in federal court.
Full text of the paper from The Open Neurology Journal, entitled “Medical Marijuana: Clearing Away the Smoke,” is available online here.