Legislation passed during the recent special legislative session will allow PROACT, a part of Marshall Health, to study the effects of methadone and buprenorphine in drug treatment. (Courtesy photo)
During this fall’s special session, state lawmakers passed a bill aimed specifically at allowing two medical research trials about opioid use disorder to be conducted in West Virginia.
The state has a moratorium on the establishment of methadone clinics. Senate Bill 2028, which Gov. Jim Justice signed into law last week, allows for the limited purposes of clinical trials approved by an institutional review board.
The law also allows advanced practice registered nurses to prescribe a three-day supply of schedule II narcotics as long as they’re doing so as part of a medical trial.
At PROACT, part of Marshall Health, researchers will participate in a three-year study comparing the efficacy of buprenorphine and methadone in the treatment of opioid use disorder. The study is being led by researchers at Yale University and the University of Pittsburgh. Besides Huntington, the study will be conducted at five other sites with a total of 600 participants nationwide.
Dr. Zachary Hansen, medical director of the division of addiction sciences at Marshall Health, is the principal investigator for the study locally. PROACT will enroll 103 patients, half of whom will be prescribed buprenorphine while the other half are prescribed methadone. Both drugs are used in medication-assisted treatment.
Researchers will follow the patients for 24 weeks to collect information on retention in treatment, outcomes of drug screenings and other factors.
“We’re doing a head-to-head comparison and methadone and buprenorphine out at a clinic or treatment setting that’s different from a methadone clinic,” Hansen said. “So it’s sort of a lower barrier sort of delivering it similar to what we do with buprenorphine versus a traditional methadone clinic.”
Researchers will try to look into recent evidence that people may be retained in treatment better with methadone than with buprenorphine. Retainment in treatment means decreasing the risk of criminal activity, infectious disease and overdose, he said.
“We’re trying to determine what can be done to help West Virginians find long term sobriety,” Hansen said. “And the data is either going to say that ‘this is helpful’ or ‘this is harmful,’ or somewhere in between, it’s neutral. But our end goal is to improve treatment for West Virginians.”
Buprenorphine may not be strong enough to treat people using fentanyl, a drug that has become much more of a factor in the state’s overdose deaths than heroin.
In West Virginia last year, 1,126 out of 1,383 drug overdose deaths involved fentanyl, according to preliminary data. By contrast, only eight drug overdose deaths involved heroin.
In 2007, West Virginia lawmakers put a moratorium on the opening of additional methadone clinics. There are nine in the state. By law, the drug can be prescribed to treat substance use disorder only at a traditional methadone clinic.
“The debate was if we’re prescribing methadone out of PROACT, even though it’s in a research setting, are we exempt from that law, because we’re only treating them for a defined period of time in a research setting or not?” Hansen said. “And the law was so old that it wasn’t very clear. And so we wanted to get the legislation sort of passed to make sure that we were 100% lawful in doing the study.”
Methadone and buprenorphine are different drugs physiologically, he said. Methadone, for instance, has a higher “risk profile,” and is theoretically more dangerous, he said. It’s rare or nearly impossible to overdose on buprenorphine, but very possible to overdose on methadone, he said.
There are also big differences in how the public perceives the drugs, Hansen said. Part of the reason for that, Hansen said, is that the restrictive way that methadone is prescribed creates a certain appearance.
“Patients go daily. They line up in long lines. They sort of go up to a window. They check in. They get a daily dose and then they go home and then they go back the next day,” Hansen said. “[It] is just a very different delivery system for care than what we do with buprenorphine, in which we give someone a week’s prescription typically at the first visit and then we just see them once a week. It’s a very different delivery system.”
Hansen said depending on the outcome of the study, it has the potential to lead to changes in how the public view’s methadone and the state’s laws that concern it.
“There’s a possibility that the data will show that there’s no difference, or the data could show the buprenorphine is superior and it’s safer,” he said. “This may definitely prove that methadone should only be done in the restrictive environment that it is. And if that’s what it shows, then we know. But if it shows that it does have characteristics or qualities that it can be done safely and it can be effective, then I think it could.”
With only nine methadone clinics statewide, people, particularly in southern West Virginia, may drive up to two hours one way for treatment, he said.
“If — it’s a big 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, yeah, then that’s somewhat tragic and that’s wrong, that we have a good medication, and patients don’t have access to it,” Hansen said. “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.”
The legislation passed easily in the Senate, 27-1. But it had a tougher time in the House of Delegates, where 50 lawmakers voted for it and 40 opposed the bill.
Sen. Tom Takubo, R-Kanawha, a physician and the vice chair of the Senate Health Committee, said lawmakers tried to narrow the bill as much to limit its application to medical studies.
“That’s why we put in there that had to be [Institutional Review Board] approved,” he said. “Which usually is doctors and lawyers and ethics people and lay persons. And they monitor closely, if it’s a study, the ethics, the safety, the feasibility, making sure that everything is staying very tightly within the guidelines of what the study is supposed to be doing. That it’s true medical research.”
Hansen said the research at PROACT will be closely regulated and monitored.
“This will be the most closely regulated trial and sort of treatment program in the state, because we’re doing this trial, the regulations are very strict,” he said. “And so we will be monitored closely, and our safety will be under constant supervision.”
Both Takubo and Del. Amy Summers, R-Taylor and chair of the House Health Committee, said West Virginia, which has had the highest drug overdose rates in the country, should take part in medical research for the opioid crisis.
“We’re really in a battle with drug addiction, and West Virginia needs to be involved in these clinical trials,” Summers said. “That way practitioners can use evidence based research to help them make decisions on how they’re going to treat people who suffer from addiction.”
Summers said the state needs more education about what medication-assisted treatment is and how it’s helping people because there seems to be bias against it. Because the bill was passed during the special session, there wasn’t time to have expert witnesses talk to lawmakers about medication assisted treatment.
Takubo said it was necessary to take up the bill during the special session and not wait until this winter’s regular session in order for a separate medical trial at West Virginia University to go forward.
PROACT is ready to start its trial within the next week or two, now that the bill is signed, Hansen said.
Summers, a nurse, said she used to think of medication-assisted treatment as replacing one drug for another, but she’s changed her mind about it over the years.
“After I saw people returning to be productive citizens of life, after getting on medicated-assisted treatment, it totally changed my mind,” Summers said. “Because they’re addicted to pain pills, and they’re not functioning, right? They’re using such high doses, and they’re not functioning in society. And then they start on this medicated assisted treatment, and they get to a dose that kind of fulfills their craving, but they’re able to function.”
Takubo said both buprenorphine and methadone can be helpful for patients being treated for substance abuse in that they help them get their lives back and prevent them from having withdrawals.
“The downside is that a lot of these clinics never try to titrate anybody off,” Takubo said. “And it’s kind of used as, unfortunately, in my opinion, it’s kind of used as an automatic cash cow because people are having to come in forever and just be using these medications.
“Well, there’s, there’s good studies and trials….. [that] within a year, a third of the people are off methadone,” Takubo said.
Takubo said the state’s laws about opioid treatment programs are aimed at curtailing abuse, not preventing people with legitimate needs from getting help. Studies will need to be done to determine how people can successfully be titrated off the drugs, and how to better stabilize people with substance use disorder, he said.
“If you don’t study it, how are you ever going to have better results than what we have now,” Takubo said. “We were ground zero that this whole thing kind of kicked off, and I think it’s important for our researchers to be able to help us determine how to best get out of this thing.”
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