CO CDPHE - A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis versus Oxycodone
Summer 2015 - Summer 2017. Back and neck pain are highly prevalent and disabling musculoskeletal conditions that affect 70% to 85% of individuals at some point in their lives. In addition to the suffering and disability it can cause for patients, spine pain has a significant social and economic impact, both for patients and for society. When conservative care and non-steroidal anti-inflammatory drugs (NSAIDS) fail to provide relief, narcotic pain medications (e.g. oxycodone) are often prescribed for patient with chronic back pain. However, narcotics are often ineffective at providing adequate relief and can result in frequent use of high doses that increase the potential for dependency and lethal overdose.
With the legalization of medical marijuana in Colorado, we anecdotally noted that an increasing number patients in our Spine Clinic reported the use of marijuana for their spine pain. Based on these findings, we conducted a pilot prospective study to assess cannabis usage patterns in patients presenting for spine surgery evaluation at our institution. In this study of 184 patients, 19% admitted utilization of cannabis, most commonly via inhalation of smoked plant material (>90%). Patients primarily used cannabis to treat their painful spinal condition, and 89% of these patients felt that cannabis moderately or greatly relieved their pain. Additionally, the large majority of respondents felt that cannabis was more effective at alleviating their pain than NSAIDs, narcotics, and nerve targeted medications.
Despite support from basic and preliminary clinical studies, the use of cannabis as an analgesic drug in the US remains controversial. Well-designed clinical trials demonstrating the therapeutic efficacy of cannabis for specific clinical indications are thus a critical factor in the social and medical debate over cannabis. However, only a small number of clinical trials have investigated the efficacy of cannabinoids for pain control, presumably due to the complex social and legal factors complicating its use in research. The majority of existing clinical trials have focused on cannabis use in patients with neuropathic pain; these trials have largely found positive analgesic results (as compared to placebo), with acceptable side effects.
Given the frequent use of cannabis by patients with chronic spine pain, there is a definite need for direct, high-quality scientific evidence regarding the clinical efficacy of cannabis in this patient population. Without such clinical trials, physicians cannot make clear, evidence-based recommendations to their patients on the use of cannabis.
The primary aim of this double-blind, within-subjects crossover trial is to determine the efficacy of cannabis in both spontaneous pain relief and experimental pain analgesia. Importantly, the analgesic effects of cannabis will be compared to both placebo and an active control (oxycodone). Given the complex nature of research on individuals with chronic spine pain (presence of comorbid conditions, tolerance to pain medications, etc.) this trial will not only include chronic spine pain patients, but will concurrently investigate the analgesic efficacy of cannabis on experimental pain in a control group of healthy individuals. Well-designed clinical trials with active controls, such as that proposed here, are critical in determining the clinical relevance of cannabis for pain control, and will present a significant contribution to the medical literature and to society.