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Methadone remains vital in buprenorphine era

October 20, 2016
by Alison Knopf, Contributing Writer
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More than 28,000 people a year die from opioid overdoses in the United States, and never before has the addiction treatment field gotten more visibility. Medication-assisted treatment (MAT) is now embraced even by many formerly “abstinence-only” treatment programs. Meanwhile, the two specialty sectors that provide MAT—opioid treatment programs (OTPs) almost exclusively using methadone, and office-based opioid treatment (OBOT) using only buprenorphine—are positioned to provide the medications more broadly to meet growing demand.

But with the increased attention by stakeholders to expand access to the office-based buprenorphine option, are OTP methadone clinics losing favor? And is there anything of a turf battle between the providers? Ultimately, experts say, there's a valuable role for both.

OTPs have existed for more than 50 years and traditionally dispensed only methadone for the treatment of addiction. Highly regulated by the federal government, OTPs are now allowed to dispense buprenorphine as well as methadone, but few have made the transition. By comparison, OBOTs, which had their start 15 years ago, only offer buprenorphine and have far fewer restrictions: A prescribing physician interested in treating addiction completes an eight-hour training course and registers with the Drug Enforcement Administration (DEA) as a Narcotic Treatment Program.

Thanks to federal rule changes, the number of physicians qualified to prescribe buprenorphine has increased—but not as fast as once predicted and not fast enough to keep pace with demand. Initially, a mandated cap limited OBOT physicians to treat only 30 patients the first year of prescribing and 100 patients after that. Under a new rule finalized in July, however, physicians now can treat up to 275 patients. More than 1,600 physicians have signed on for the increase as of October, according to federal officials. Many observers believe it's still not enough.

Apples and oranges

What is clear is that both modalities have been growing with the opioid epidemic. The number of patients receiving methadone treatment in OTPs has been steadily increasing, according to Substance Abuse and Mental Health Services Administration (SAMHSA) statistics, as have the number of patients in treatment with physicians waivered to provide buprenorphine under the Drug Addiction Treatment Act of 2000 (DATA 2000).

The use of buprenorphine in OBOT was conceptualized and is practiced differently from the treatment offered in an OTP, with very different regulations on a state-to-state basis, says Kelly J. Clark, MD, president-elect of the American Society of Addiction Medicine (ASAM), which represents numerous DATA 2000 providers. “Some states have substantial buprenorphine restrictions in place, with some being counter to what we know is quality and effective care,” she says.

Clark, who is chief medical officer of CleanSlate Centers, a Massachusetts-based buprenorphine clinic chain, also has worked in an OTP. But it’s difficult to compare the two kinds of treatment, she says. “As with most medical care, we have unfortunately little comparative analysis between known effective treatment options,” she says.

Because the vast majority of data on buprenorphine comes from an office-based environment and the only data on methadone comes from clinic settings, any comparisons between the two medications are really just comparing OBOT and OTP. “It’s an apples and oranges situation,” says Clark.

She believes buprenorphine has several clinical advantages over methadone. Methadone is a full agonist with a higher risk of overdose compared to buprenorphine, she says. Buprenorphine also has a longer duration of action than methadone.

While the medications work in similar ways, the differences between treatment in a doctor's office and treatment in an OTP are stark. With buprenorphine, a physician provides the induction (initial dose) while the patient is in some withdrawal. From then on, the physician provides monthly prescriptions, which the patient fills at a pharmacy. Some buprenorphine physicians elect to provide additional services, especially in early treatment—mainly the physicians who are addiction specialists. There is no requirement for counseling or drug testing with buprenorphine provided in an OBOT setting, although these services are recommended.

Patients in OTPs, however, must come in for their methadone dose every day at first. Clinics often are located far from the patient's residence. Dosing hours are usually in the early morning or evening, so that patients can get to work, but it is still an inconvenience for many. However, OTPs also provide comprehensive care, offering wraparound services such as employment counseling, case management and drug testing. As patients stay in treatment longer, they in some cases can earn “take-home” doses of the drug, and in some states, that can be a month’s worth.

Buprenorphine's rapid development

The federal government provided the funds for the development of buprenorphine (as brand drug Suboxone) under the National Institute on Drug Abuse (NIDA) and SAMHSA. The most difficult part of the development involved combining buprenorphine with naloxone, an approach taken to combat diversion. Today, the federal government, in the face of the increasing urgency of an opioid epidemic, has been trying to get OBOT into more widespread use.

H. Westley Clark, MD, professor of public health at Santa Clara University, has studied both medications. He was director of SAMHSA’s Center for Substance Abuse Treatment (CSAT) when buprenorphine was developed and when it went through the growth process to full commercialization. He also has participated in OTPs for the Department of Veterans Affairs and others.

He says some healthcare stakeholders saw buprenorphine as a quick panacea.