West Virginia has enacted a bill to facilitate medical research trials focused on opioid use disorder, paving the way for a significant study comparing the effectiveness of buprenorphine and methadone. The legislation, signed into law by Gov. Jim Justice, addresses a moratorium on new methadone clinics, allowing for clinical trials approved by an institutional review board.
The study, spearheaded by researchers at Yale University and the University of Pittsburgh, will be conducted at six sites nationwide, including the PROACT clinic at Marshall Health in Huntington, West Virginia. Dr. Zachary Hansen, medical director of the division of addiction sciences at Marshall Health, will serve as the principal investigator for the local arm of the study. PROACT plans to enroll 103 patients, with half receiving buprenorphine and the other half methadone, both medications used in medication-assisted treatment (MAT).
Head-to-Head Comparison
The study is designed as a direct comparison of methadone and buprenorphine in a treatment setting that differs from traditional methadone clinics. "We’re doing a head-to-head comparison of methadone and buprenorphine at a clinic or treatment setting that’s different from a methadone clinic," Hansen explained. "So it’s a lower barrier treatment delivery similar to what we do with buprenorphine versus a traditional methadone clinic."
Researchers will monitor patients for 24 weeks, gathering data on treatment retention rates, drug screening results, and other relevant factors. The primary goal is to determine which medication leads to better patient retention, a critical factor in reducing criminal activity, infectious disease transmission, and overdose risk.
Addressing the Fentanyl Crisis
The urgency of this research is underscored by the escalating fentanyl crisis in West Virginia. In 2023, preliminary data indicated that 1,126 out of 1,383 drug overdose deaths in the state involved fentanyl, while only eight involved heroin. Hansen noted that buprenorphine may not be potent enough to effectively treat individuals using fentanyl.
Legislative Support and Oversight
The bill received bipartisan support, passing easily in the Senate (27-1) but facing more opposition in the House of Delegates (50-40). Sen. Tom Takubo, R-Kanawha, emphasized the importance of limiting the bill's application to strictly medical studies, ensuring ethical and safety standards are maintained through Institutional Review Board approval.
Del. Amy Summers, R-Taylor, highlighted the necessity of West Virginia's involvement in opioid crisis research, given the state's high drug overdose rates. She also noted the need for greater education about medication-assisted treatment to combat existing biases.
Potential Impact on Methadone Access
Currently, West Virginia has only nine methadone clinics, leading to access challenges, particularly in southern regions where patients may travel up to two hours for treatment. Hansen suggested that positive study outcomes for methadone could prompt a reevaluation of the state's moratorium and lead to improved access to the medication.
"If we find the methadone is efficacious and we can deliver it safely, and it is, in some aspects, better than buprenorphine, then that’s somewhat tragic and that’s wrong, that we have a good medication, and patients don’t have access to it," Hansen stated. "And that access needs to be addressed, which would become down toward we’d have to remove the moratorium, and we have to find a way to safely get methadone to individuals, regardless of their geographical locations."
