WVU Study to Compare Buprenorphine Formulations for Opioid Use Disorder in Rural Setting
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West Virginia University (WVU) will conduct a study comparing oral film versus injectable buprenorphine for opioid use disorder (search) treatment in rural areas.
The study, funded by the National Institute on Drug Abuse, will involve 24 patients at a clinic in New Martinsville, Wetzel County, and six other sites nationwide.
Senate Bill 2028 allows researchers to dispense larger amounts of buprenorphine directly to study participants, bypassing pharmacy distribution.
A West Virginia University Rockefeller Neuroscience Institute researcher will lead a study comparing two formulations of buprenorphine for treating opioid use disorder (search) in a rural setting. Dr. Laura Lander, an associate professor in the Department of Behavioral Medicine and Psychiatry, will serve as the primary investigator for the research, which aims to evaluate the effectiveness of oral film versus injectable buprenorphine in patients at the New Beginnings Recovery Clinic and Behavioral Health Center in New Martinsville, Wetzel County.
The study, funded by the National Institute on Drug Abuse (NIDA), will enroll 24 patients from the New Martinsville clinic and extend to six additional sites across the country. The research will focus on whether patients in rural settings are able to maintain abstinence from drugs, whether their lives improve, and how their mental health symptoms are going.
Senate Bill 2028, recently passed, enables researchers at the Wetzel County site to dispense larger quantities of buprenorphine directly to patients participating in the study, rather than relying on pharmacy distribution. This legislative change was specifically tailored to facilitate the WVU study and a separate study at PROACT, a Huntington clinic affiliated with Marshall Health (search).
"So we’ll see if the outcomes are any different on the injectable medication or on the oral medication," Dr. Lander stated.
Dr. Lander emphasized the unique challenges faced in rural settings like West Virginia, including transportation barriers and a scarcity of healthcare providers proficient in the latest evidence-based treatments. The study aims to involve providers in understanding and implementing up-to-date treatment approaches, thereby directly benefiting patients.
Buprenorphine film, an oral formulation, has been used in medication-assisted treatment clinics for at least a decade, while the monthly injectable form represents a more recent development. While Senate Bill 2028 was enacted to support research at Marshall and WVU, it faced opposition in the House of Delegates due to concerns about the expansion of medication-assisted treatment and potential exacerbation of drug-related problems in the state.
Dr. Lander underscored the importance of West Virginia's participation in clinical trials focused on opioid use disorder (search), given the state's high drug overdose rates. She argued that restrictions on researchers' involvement in such trials are detrimental to the state, highlighting the stringent regulatory oversight of national clinical trials designed to protect patients.
"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."
With Senate Bill 2028 specifically applicable to the studies in Wetzel County and Huntington, future research endeavors will require further legislative engagement. Dr. Lander expressed enthusiasm for the innovative research being conducted in West Virginia regarding substance use disorders and highlighted the willingness of patients to participate in clinical trials and contribute to scientific advancements.