By BETSY TAYLOR
Saint Francis Hospital and Medical Center in Hartford, Conn., is researching the effectiveness of medical marijuana for pain relief in patients with multiple rib fractures. The intent of the research is to see how effective medical marijuana is at pain control for a condition for which patients currently receive prescription opioids. Researchers will investigate whether people taking the marijuana require fewer or lower doses of the opioids to manage pain.
The research comes at a time when opioid addiction is plaguing communities across the country, with opioid-related deaths in the United States at an all-time high in 2015, the most recent available federal data.
Feeney
Dr. James M. Feeney, Saint Francis' director of trauma services and of surgical research, said in January that an open-label proof of concept trial is underway. That's a type of clinical trial in which researchers and the participants know which treatment is being administered. He said 60 patients total will take part in this phase of the research by the time it's complete, over the course of about six to eight months.
To be eligible for the study, patients must have least three cracked ribs and be at least 18 years old. Individuals cannot take part if they have a history of habitually using narcotics or marijuana.
All 60 patients will receive a prescription for oxycodone, an opioid medication. Patients will begin on 5 to 10 milligrams of oxycodone, which they may take every three or four hours, as needed, for pain. The opioid dosage can be increased by their physician, if the patient needs more pain relief.
Half of the 60 patients in the trial also will take medical marijuana, and begin with a capsule in the morning and a capsule at night. Each capsule contains 10 milligrams of cannabidiol, or CBD, and 10 milligrams of tetrahydrocannabinol, or THC, two of the molecules that make up marijuana. The 30 patients given medical marijuana will be allowed to add a third marijuana dose in a day for pain control. Patients also will be given a THC oral spray, which delivers 4 milligrams of the drug, to treat breakthrough pain. Patients using the medical marijuana also may take a prescribed dose of the opioid if they require it for pain relief, Feeney said.
At the time they are discharged from the hospital, participants will fill out detailed health surveys with questions about their pain level, well-being, mental health and activity level. They'll repeat the survey six weeks later for comparison, Feeney said.
Participants will keep pain journals, in which they record how they're feeling and rate their pain from one to 10 multiple times a day and record the amount of medication they consume daily. Researchers will calculate the milligrams of morphine used by each individual — a measure of the amount of opioids each patient has taken — to gauge if patients using both medical marijuana and opioids had a reduced opioid intake compared with the control group.
"The data we have from the chronic pain literature is that people need less opiate for pain control when the two are used together," Feeney explained.
Patients are taking low doses of the medical marijuana in a formulation that takes effect over hours, so they may experience a feeling of euphoria, but they're not getting "high" as they would from smoking marijuana, he said. "Of course, just like with opiate pain medication, we advise our patients not to drive or operate machinery while using the medication."
Feeney said of the research, "We believe there has to be an answer to the opioid epidemic." He said over the years he has treated a handful of patients with broken bones who refused opioids and told him they planned to smoke marijuana for pain relief instead.
The researchers hope to follow their initial study with a larger randomized control trial, which would cost about $300,000, he said.
Feeney said six trauma surgeons at Saint Francis are funding the initial study because it was difficult to find external funding sources. Feeney even sent a letter to country artist Willie Nelson to invite his monetary sponsorship; the musician is public about his enthusiasm for recreational marijuana use. Feeney hasn't heard back directly from Nelson.
The legality of using marijuana varies around the country.
In Connecticut, patients can legally obtain marijuana for medical use if they are certified by a doctor as having one of 22 conditions.
In 2016, Connecticut passed a law allowing medical facilities licensed through the Department of Public Health as well as institutions of higher education and licensed medical marijuana dispensaries and producers to apply for research licenses through Connecticut's Department of Consumer Protection.