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Large-Scale Trial Assesses Cannabis Safety, Abuse Potential in Chronic Pain Patients David Wild PainMedicineNews Wednesday 22 May 2013 According to David Bearman, MD, a physician in private practice in Goleta, Calif., and a board member of the American Academy of Cannabinoid Medicine, the findings presented at the International Association for the Study of Pain’s (IASP) 14th World Congress on pain in Milan support the view that "cannabis has substantially fewer and less severe side effects not only than other analgesics but also than the antidepressant and antiepileptic drugs that cannabis can replace or be used in concert with." In one study, Haggai Sharon, MD, a researcher at the Center for Pain Medicine and the Functional Brain Center at the Tel Aviv Souraski Medical Center and Tel Aviv University, in Israel, and his colleagues examined data from 419 male and 298 female chronic pain patients treated with cannabis between 2009 and 2012 (abstract PT 411). Patients were an average of 51 years (range, 24-99 years). The most common diagnoses were degenerative spinal disease, cancer, medical neuropathy, fibromyalgia, arthritis, central nervous system diseases, peripheral vascular disease or inflammatory bowel disease. Most participants had dual diagnoses. All the patients had failed to adequately respond to prior nonopioid and opioid-based treatments, as well as interventional procedures. Before beginning treatment, a medical psychologist interviewed the patients. Participants with a history of psychiatric diagnosis or drug abuse or those taking psychiatric medications required a letter of approval from a psychiatrist. Patients attended follow-up appointments every three months for the duration of treatment and those with treatment-related adverse events were followed with the Short Form-26 (SF-26) questionnaire. Dr. Sharon said most patients started treatment at a dose of 20 to 40 g per month, with 9% (65 of 100) requiring a dose escalation up to 100 g per month following an inadequate response with the starting dose. In terms of treatment adherence and tolerability, 4.4% of patients (32 of 717) terminated therapy because of a lack of efficacy and 1.5% (11 of 717) stopped because of side effects, including anxiety, weakness or dizziness that interfered with daily functioning. In an email interview with Pain Medicine News, Dr. Sharon noted that nearly 200 of the patients were between the ages of 70 and 79 and approximately 80 were aged 80 to 89. Only five of the latter group opted out of treatment, he said. "Doctors and health care professionals should consider cannabis use earlier, and patients—particularly the elderly-should be informed of this option," Dr. Sharon stated. "Although it is impossible at this stage to assess the pure analgesic effect of cannabis treatment, the overall beneficial effects on quality of life in chronic pain patients are evident," he noted. Commenting on Dr. Sharon's review, Dr. Bearman said, "the study documents the many clinical indications for cannabinoids that are well known to any cannabinoid medicine clinician." A second study presented at the IASP meeting, this time examining the abuse potential of cannabinoids, was conducted by Mark Ware, MD, associate professor in the Departments of Anesthesia and Family Medicine at McGill University in Montreal, Quebec, Canada, and his colleagues (abstract PT 413). The researchers enrolled 265 chronic pain patients receiving prescription cannabinoid treatment to participate in a prospective, observational, one-year study. Cannabinoids included nabiximols (Sativex, GWPharma), a cannabinoid oromucosal spray; nabilone (Cesamet, Meda), an oral synthetic cannabinoid; and dronabinol (Marinol, Abbott), a pure isomer of tetrahydrocannabinol (THC). Most participants were white and female (average age, 49 years). The most common indications for treatment were musculoskeletal, psychiatric, neurologic and gastrointestinal conditions. Given a paucity of cannabinoid-specific clinical instruments to measure abuse risk, Dr. Ware's team adapted a series of opioid abuse measures, administering them at study outset and then at three, six and 12 months. These included the Chabal Prescription Abuse Checklist (CPAC; score ?3 suggests abuse), the Current Opioid Misuse Measure (COMM; score ?9 indicates potential misuse) and the Addiction Behaviors Checklist (ABC; score ?3 suggests risk for abuse), among other measures. According to Dr. Ware, between 22.3% and 28.5% of patients met the COMM cut-off criteria for drug misuse at various time points. However, other measures produced conflicting results. For example, none of the patients met CPAC cut-off scores at any of the time points and 12% or fewer patients met the ABC cut-off scores. "The level of abuse or risk for abuse we found very much depended on the type of instruments we used," Dr. Ware told Pain Medicine News, noting that his team is considering developing cannabinoid-specific abuse measures and screening tools. "While this made it difficult to draw conclusions on whether there was a risk for abuse or actual abuse taking place, in most cases treating clinicians did not feel their patients were significantly abusing the medication." Dr. Ware added, "although there are no head-to-head trials comparing prescription cannabinoid abuse and opioid abuse, the level of abuse risk and the incidence of abuse with cannabinoids does not seem to be as great as with opioids." The results of the two studies suggest prescription cannabinoids may be safe and are associated with a low risk for abuse in certain individuals, but the class of drugs is far from benign, said Marcel Bonn-Miller, PhD, a health science specialist at the Center of Excellence in Substance Abuse Treatment and Education at the Philadelphia Veterans Affairs Medical Center. "There is significant evidence of the harms of heavy cannabis use, including exacerbation of anxiety and depression, as well as poor lung functioning," said Dr. Bonn-Miller, who is also a health science specialist at the National Center for Post-Traumatic Stress Disorder and the Center for Health Care Evaluation, VA Palo Alto Health Care System, in California. "Cannabis is also highly addictive, with individuals who use it regularly having significant difficulty abstaining from use." He added that, "since there are many strains of cannabis, each with differing levels of active cannabinoids that have been shown to differentially affect pain and anxiety, for example, there is significantly more work that is needed before any standard in terms of dosage is achieved." http://www.painmedicinenews.com/ViewArticle.aspx?d=Clinical%2BPain%2BMedicine&d_id=82&i=May+2013&i_id=951&a_id=23056
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