Opioid treatment programs (OTPs) have always been able to dispense buprenorphine on the same basis as methadone, but now they can dispense take-home buprenorphine more liberally than take-home methadone. This has given rise to many questions about how new patients should be selected for which medication—the appeal of take-homes is clear, but that doesn’t necessarily mean everyone who wants buprenorphine from an OTP should get it. Still, there is very little information available about how to select which patients for which medication. AT Forum talked to top experts in the country about this question.
There aren’t formal selection criteria developed for OTPs, explained Melinda Campopiano, MD, medical officer for the Center for Substance Abuse Treatment (CSAT) at the federal Substance Abuse and Mental Health Services Administration (SAMHSA). Dr. Campopiano said physicians should apply exclusionary criteria for each medication, but aside from that, the decision is “supposed to be made by a physician, based on individual circumstances.”
It’s clear, said Dr. Campopiano, that more is involved than simply patient choice. “How healthy is the patient medically and psychiatrically? How stable is their life? Can they keep take-home medication safely?”
Andrew J. Saxon, MD, professor in the Department of Psychiatry & Behavioral Sciences and director of the Addiction Psychiatry Residency Program at the University of Washington, prefaced his answers to our questions by saying there are no good data that would help predict which patients might do best on which medication. “My responses involve my own opinion,” he said. He is trying to “piece together the data we do have to lead us at least to some reasonably rational decisions.”
Dr. Saxon noted that the situation is no different from any other area of psychiatry—“We have lots of antidepressants and antipsychotics, but no data to tell us which patient will respond best to which” drug.
That said, methadone has the advantage of retaining patients better in treatment, said Dr. Saxon. “This advantage is very important because so many patients drop out of maintenance treatment, and almost all relapse and significantly raise their risk for mortality.”
The advantage of buprenorphine is a better safety profile, allowing the dose to be raised very quickly to therapeutic levels, said Dr. Saxon, who was the source recommended by the National Institute on Drug Abuse for this article.
If what people want is a formula that gives cookie-cutter recommendations for one drug over the other that can apply in all cases—that isn’t going to happen, said Dr. Campopiano. “You can’t use a formula to tell you what medication to give for blood pressure. You might try one, and if that doesn’t work, try another.” It’s important to rely on science, she said.
One of the big challenges with medication-assisted treatment—and all treatment—for addiction is that the field is short on physicians, unlike other medical treatment fields. This creates a struggle when it comes to answering questions about different medications. A choice between buprenorphine and methadone is, after all, a medical decision.
The decision to treat with buprenorphine or methadone is based on a combination of factors, said Laura Murray, MD, medical director for Addiction Services for NHS Human Services. Dr. Murray oversees medication-assisted treatment with methadone and buprenorphine in multiple OTPs in Philadelphia and surrounding counties. “In our treatment programs, the process begins with a thorough intake assessment to first determine the appropriate level of care, whether that be inpatient treatment or treatment in the OTP setting,” said Dr. Murray. After review and collaboration with the intake specialist, the final decision for the appropriate form of medication is made by the physician, she said.
A history of patient reliability, patient choice, and a history of response or lack of response to buprenorphine or methadone would guide Peter L. Tenore, MD, medical director of the division of substance abuse at Albert Einstein College of Medicine in New York City. However, patient preference is not as important as the patient’s responsibility in taking medications correctly.
Dr. Tenore stressed that a patient’s desire to have take-homes is not alone a valid criterion for dispensing buprenorphine instead of methadone. Patient responsibility—to take medications correctly and to prevent diversion—and patient history of or a response or nonresponse to buprenorphine—are the important issues, he said.
“Patient preference guides me a lot,” said Dr. Saxon. “We have a qualitative study showing that patients who prefer methadone but get buprenorphine instead are not well satisfied and don’t stay on it,” he said. “Since we don’t have good data to guide us in making a choice between medications, why not give the patient what the patient wants, unless there are reasons not to?” He added that one reason not to would be that the patient hasn’t done well on that medication before.
Individual preference is a major factor in the decision between methadone and buprenorphine, agreed Dr. Murray. “If an individual presents requesting buprenorphine treatment, we make every attempt to accommodate their preference,” she said. “When a person struggling with addiction has reached the point of accepting the need for help, denying their preferred treatment can be antagonistic and harmful in establishing a therapeutic relationship from the outset.”
However, Dr. Murray noted that the program is “very clear from the beginning that the final decision rests with the program physician after a complete examination and an assessment of appropriateness for treatment,” she said. If patient preference cannot be accommodated, the program works with the patient to help him or her “in a mutual understanding regarding the appropriate treatment and the reasons for the denial.”
Patient preference should be taken into consideration, because patients do better when OTPs “meet them where they’re at,” said Susan F. Neshin, MD, medical director of JSAS Healthcare, an OTP based in Neptune, New Jersey.
If patients’ main reasons for wanting buprenorphine are take-homes, they need to realize that there are more stringent requirements for these privileges.
The more liberal take-home policy for buprenorphine is often attractive for people who are holding down full-time jobs or for mothers with child-care issues, said Dr. Murray. “However, we are very aware of diversion issues and as such we attempt to make an assessment regarding the type of program and the level of structure best suited to the individual, based on their presentation and history.”
“A patient appropriate for buprenorphine treatment should have relative stability in many important life areas,” said Dr. Neshin, citing employment, housing, relationships, physical and mental health, and support systems. “Patients whose lives are more chaotic need the structure of methadone treatment,” which means coming to the clinic more often.
Array of Services
OTPs offer a broad array of services, and many patients benefit from this. However, many patients are unwilling to commit to the daily attendance and stringent requirements of OTPs. “The stronger their own support systems and commitment to recovery, the less they need the structure of OTPs,” said Dr. Neshin.
It’s not possible to compare office-based treatment with buprenorphine and treatment in the OTP setting (with either buprenorphine or methadone), because of the extra services offered by an OTP. Dr. Tenore demands and arranges for additional services for patients on buprenorphine, as well as for those on methadone.
Treatment in an OTP and office-based treatment are “probably not comparable,” agreed Dr. Saxon, adding that no study has even been done comparing the two settings. “Right now we suspect that patients who make it to office-based treatment are probably different from those who end up in OTPs, with OTP patients being generally sicker and poorer. But I’m not sure we have adequate data to support that.” And, he stressed, dropout rates from office-based treatment are very high.
In general, patients with a high opioid tolerance and chronicity of use in general should be guided to methadone treatment, said Dr. Neshin. But she added that many patients with apparent high tolerances can comfortably reach an adequate buprenorphine dose.
For people who have a history of instability on buprenorphine, chances are it won’t be efficacious when tried again, unless there are significant changes in the patient’s circumstances, Dr. Neshin noted.
But clinicians should look beyond a history of failure with either buprenorphine or methadone to the reason for that failure, said Dr. Tenore. Usually, he said, the reason for the failure is that the dose was too low.
Previous failures can make a difference in which medication is chosen, but should never be used alone as a deciding factor, said Dr. Murray. She agreed that the reasons for failure are important. In addition, she said, a past failure with a specific treatment “can lead to a positive outcome in a future attempt, because the individual has learned something from the failed attempt.”
Specific Drug of Abuse
All of our sources agreed that whether patients were addicted to heroin or prescription opioids is not relevant in deciding between methadone and buprenorphine.
But if the patient used opioids intravenously, the structure of an OTP is preferred, regardless of the medication delivered. These patients are more likely to have higher addiction severity scores, noted Dr. Neshin.
Typically, patients with longer addiction histories and longer periods of instability in their lives should be referred for methadone treatment in an OTP, Dr. Neshin said. And while age isn’t an important factor, “immaturity” usually requires the structure of an OTP, she added.
Dr. Murray agreed completely on maturity of the patient playing a role in choice of treatment. While both methadone and buprenorphine patients should be at least 18 years of age, it’s important to determine whether the patient can be compliant with treatment requirements. Younger patients benefit from the more structured environment of methadone maintenance treatment, according to Dr. Murray. “Lifestyle and support systems are important factors in determining the appropriate treatment,” she said, adding again that the more structured environment of methadone maintenance treatment “may be more appropriate for a person without support systems and with an unstable living environment.”
OTP vs. Office-based
Often, the question of methadone vs. buprenorphine is interpreted as one of OTP vs. office-based treatment. That came up frequently in our interviews, because methadone is still associated with OTPs, and buprenorphine with office-based treatment.
But it’s important to realize that buprenorphine can be given in either setting, and that the fact that patients are allowed buprenorphine take-homes under federal guidelines doesn’t mean that an OTP will make the clinical decision that patients should have take-homes. In other words, methadone always must be dispensed in an OTP (with very rare exceptions), while buprenorphine can be dispensed in an OTP or by an office-based practitioner.
In deciding between an office-based model and an OTP when giving buprenorphine, IV drug users should be steered toward an OTP unless the office-based practitioner is “conscientious about all the necessary medical testing that needs to be done,” said Dr. Neshin, citing in particular HIV and hepatitis testing.
At NHS, all addiction treatment, whether with methadone or buprenorphine, includes multiple ancillary services, said Dr. Murray. “We believe that for most people, medication-assisted treatment does not work alone.”
Among the ancillary services that should be offered in addition to medication: group and individual therapy, family therapy, case-management services, services for specialized groups such as seniors and pregnant women, enhanced recovery services, peer specialist supports, and on-site psychiatric services—these are all offered by NHS. While some office-based providers give referrals for counseling elsewhere, many are not in a position to provide these ancillary services, said Dr. Murray. And it’s often the OTPs who have to pick up the pieces when the services aren’t provided. “We sometimes treat patients who have failed treatment in an office-based treatment setting because they needed a higher level of care or other services to support their recovery, and these were not made available to them.”
Pregnancy status is less relevant as a patient-selection criterion than it used to be, now that enough studies have been done using buprenorphine during pregnancy, said Dr. Neshin. “However, I have had many women who started out on buprenorphine and had to switch to methadone during pregnancy due to inability to reach an adequate buprenorphine dose as the pregnancy progressed,” she said.
There are differences of opinion about this issue, with CSAT’s Dr. Campopiano saying that not enough studies have been done to make clinicians comfortable prescribing buprenorphine during pregnancy, and Dr. Tenore of Albert Einstein saying he would absolutely not prescribe it, citing U.S. Food and Drug Administration (FDA) guidelines.
Dr. Murray conceded that recent studies do suggest positive outcomes with buprenorphine treatment, but she said that methadone maintenance “is still the standard of care, and would be our preferred treatment at this time for a pregnant woman seeking treatment.”
There are huge differences in cost between methadone, which is very inexpensive, and buprenorphine. In New Jersey, for example, if a patient has Medicaid and little money, it is often less expensive to be on office-based buprenorphine than on methadone, Dr. Neshin explained. Many OTPs in New Jersey either do not accept Medicaid or limit the number of Medicaid patients they can treat, and many Medicaid patients have to pay the standard weekly clinic fee. Since Medicaid covers the cost of a buprenorphine prescription, patients may have to pay only a monthly fee to an office-based physician. On the other hand, patients without prescription coverage often cannot afford buprenorphine treatment, as even the cost of generic buprenorphine can be prohibitive.
At NHS, cost is irrelevant, since the only out-of-pocket expense is a “very minimal co-pay for buprenorphine prescriptions,” said Dr. Murray. She explained that patients already in treatment with buprenorphine often are admitted to NHS because they can’t afford the cost of an office visit with their office-based provider.
Some patients want to “graduate” from methadone to buprenorphine, mainly because they are unable to attend the OTP as frequently as methadone treatment requires, said Dr. Neshin, who has transferred many patients for this and other reasons. Typically, the transfer is done with “minimal discomfort,” and patients usually stabilize within days.
Sometimes the transfer is from buprenorphine to methadone—for example, if a patient isn’t doing well in office-based treatment and continues abusing drugs, a referral to medication-assisted treatment in an OTP—or in some cases, to inpatient treatment—should be made, said Dr. Neshin.
If issues of cost are ignored, said the University of Washington’s Dr. Saxon, “it makes sense to start with buprenorphine with a back-up plan to switch promptly to methadone if the response to buprenorphine is not good.” He added that it’s important for patients to know that it’s “easy to switch from buprenorphine to methadone, but it can be quite challenging to switch from methadone to buprenorphine.”
Overall, the determination to treat with methadone or buprenorphine is multifactorial. Methadone maintenance in an OTP provides greater structure because the individual has to visit every day for dosing, or to attend group sessions and counseling. Patients who want take-home buprenorphine are expected to be reasonably compliant with treatment and safety precautions. Patients who have untreated or unstable psychiatric comorbidities, or are currently abusing or dependent on sedative-hypnotic drugs or alcohol (in addition to opioids) may be recommended for methadone treatment in an OTP instead of treatment with buprenorphine.