Legislation that passed during the recent special session will allow research about buprenorphine at New Beginnings Recovery Clinic and Behavioral Health Center in New Martinsville, W.Va. (West Virginia University Rockefeller Neuroscience Institute photo)
A bill passed during this fall’s special legislative session will allow a researcher with the West Virginia University Rockefeller Neuroscience Institute to study buprenorphine at a Northern West Virginia clinic.
Dr. Laura Lander, an associate professor in the Department of Behavioral Medicine and Psychiatry, will be the primary investigator for the study, which will compare the use of buprenorphine in an oral film versus an injectable form of the drug in patients in rural settings.
Twenty four patients from New Beginnings Recovery Clinic and Behavioral Health Center in New Martinsville, Wetzel County, will be part of the study, which is funded through the National Institute on Drug Abuse. The research will take place at six additional sites across the country.
Lander said Senate Bill 2028 will allow researchers at the Wetzel County site to dispense larger amounts of buprenorphine directly to patients involved with the study instead of through a pharmacy. Lawmakers limited the legislation to allow the study at New Beginnings along with a separate study at PROACT, a Huntington clinic that’s part of Marshall Health.
Lander said the study will focus on patients in rural settings and look at whether they are able to maintain abstinence from drugs, whether their lives improve, and how their mental health symptoms are going.
“So we’ll see if the outcomes are any different on the injectable medication or on the oral medication,” she said.
Rural settings like West Virginia present different challenges than urban settings, like transportation barriers and a lack of health care providers who are well versed in the latest evidence-based treatment, she said.
“So this is also a way to really get providers involved in knowing, because they’re participating in studies and knowing what the most up-to-date evidence based treatment is, and getting that treatment directly to patients,” Lander said.
Buprenorphine film, an oral form of the drug, has been used in medication assisted treatment clinics for at least the past 10 years, she said. A monthly injectable form of the drug is newer, she said.
While the legislature passed Senate Bill 2028 specifically to allow the research by Marshall and WVU, the bill was met with some resistance, particularly in the House of Delegates, where 40 lawmakers voted against it. Some raised concerns the legislation could lead to the expansion of medication assisted treatment and cause more drug problems in the state.
Lander said it’s important for the state — which has one of the highest drug overdose rates in the country — to be a part of clinic trials focusing on opioid use disorder. Laws that restrict researchers from participating in clinical trials are a disservice to the state, she said.
“When someone is engaging in a large-scale national clinical trial, the regulatory oversight of every move that is made by the study staff is intense,” she said. “And so the idea that the state thought that this was a risk for the people of the state, I think, is a little bit misguided, because national clinical trials are heavily regulated to protect patients.”
Senate Bill 2028 applied only to the studies at the Wetzel County clinic and one at PROACT in Huntington, so researchers will need to approach lawmakers in the future if they’re participating in future studies, she said.
“West Virginia is doing some really, really exciting research in the area of the study of substance use disorders. It’s nice to be recognized for that innovation and really being able to address the problems in the state and be part of the solution,” Lander said. “And what I have been continually just so happy about is that patients want to be in clinical trials. They want to be part of that solution also. They really want to contribute to this science. So it’s important for us to be able to allow them to do so.”
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