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NEW ORLEANS – Physicians committed to fighting the national opioid epidemic really need to take the 8-hour training course on addiction treatment required to obtain a Drug Enforcement Administration ‘X’ number, because it will enable them to prescribe buprenorphine, a drug with unique advantages for many affected patients, Ellie Grossman, MD, asserted at the annual meeting of the American College of Physicians.
Buprenorphine (Subutex) is one of the three medications approved for treatment of opioid use disorder (OUD), along with methadone and naltrexone (Revia). And for certain patients, it’s clearly the best choice, according to Dr. Grossman, a general internist at Harvard Medical School, Boston, and the primary care lead for behavioral health integration at the Cambridge (Mass.) Health Alliance.
The DEA X number certification process, which entails obtaining a waiver through SAMHSA – the Substance Abuse and Mental Health Services Administration – is bureaucratic. It’s unpopular with many physicians. But it’s well worth 8 hours of an internist’s time to get the waiver and gain the ability to prescribe buprenorphine.
“The requirement is admittedly clunky, and many people have strong feelings about whether this is a regulation that should exist,” according to Dr. Grossman. “I myself didn’t need to have special training to prescribe methadone, a full opioid agonist that my patients could easily die from. But I did have to undergo an 8-hour training to prescribe buprenorphine, and it’s much harder to die from that drug.”
She addressed which of the three medications for OUD is the best fit in a given patient, the appropriate treatment duration, and the role of adjunctive counseling, which – spoiler alert – has been cast into question by the results of a major government-funded randomized trial.
Dr. Grossman’s overriding message: “You are saving lives by getting people on medication.”
Indeed, studies have shown that patients with OUD who receive no treatment have a sixfold increase in the standardized mortality ratio, compared with the general population. Contrast that with the less than 2-fold increased risk with medication-assisted treatment and roughly a 2.5-fold increased risk when medication is given short term to cover withdrawal and then tapered and discontinued.
Other documented benefits of long-term medication-assisted treatment of patients with OUD as described in a 2014 Cochrane review include reductions in injection drug use, crime days, HIV-related risk behaviors and seroconversion, and improved health and social functioning.
Of note, those well-documented benefits apply only to methadone, a full opioid agonist, and buprenorphine, a partial agonist, because those two drugs have been around long enough to generate long-term outcome data. Naltrexone, which has a completely different mechanism of action – it’s a full opioid antagonist – has not as of yet.
Individualizing medical therapy for OUD
Physicians can’t write a prescription for methadone. The drug must be administered at a certified opioid treatment program, or OTP, otherwise known as a methadone clinic. Those clinics are highly regulated at both the federal and state levels, with lots of minutia involved. Patient counseling and drug screening are required.
In contrast, a physician with a DEA X number can write a prescription for buprenorphine and have a patient fill it at a pharmacy. There is inherently less structure surrounding buprenorphine therapy than that of methadone, Dr. Grossman noted. There are no hard and fast rules about how often a physician has to see the patient or do drug screens or counseling. Buprenorphine is available as once-daily oral sublingual therapy and, more recently, in long-acting injectable and implantable formulations, although Dr. Grossman believes the jury is still out about how these nonoral agents are best utilized.
“I’m often asked, ‘Which is better, methadone or buprenorphine?’ Really, the answer is they’re both pretty darn good,” according to Dr. Grossman.
The Cochrane review concluded that, in the studies that have used real-world dosing – that is, higher doses than in the initial studies – high-dose buprenorphine and high-dose methadone have similar rates of retention in treatment.
“What I tell patients is that a lot hinges on the structure of the treatment delivery system,” Dr. Grossman said. “If it’s methadone, they’re going to the OTP every day. Some people need more structure; they need a set of eyes on them every day. Or if they are at high risk for medication diversion – for example, someone else in their household might want to steal their medications – going to a methadone program gets around that. Also, when somebody has been on methadone in the past and did well on it and wants to go on it again, I’m likely to say, ‘That sounds like a good fit.’”
Buprenorphine is a good option for patients who don’t require close, structured supervision. It has fewer drug interactions than does methadone and is less prone to cause QTc prolongation. Also, it’s a more realistic option for patients who live so far from an OTP that daily attendance is impractical. And ob.gyns increasingly favor buprenorphine, because the problem of neonatal abstinence syndrome is less severe than when mothers are on methadone.
As for extended-release naltrexone (Vivitrol), the pivotal double-blind Russian trial that won FDA approval for treatment of OUD showed a dramatic improvement in opioid-free weeks (Lancet. 2011 Apr 30;377[9776]:1506-13).
More recently, the 24-week, multicenter, open-label X:BOT trial randomized 570 U.S. patients with OUD to once-monthly extended-release naltrexone or daily sublingual buprenorphine-naloxone (Suboxone). The dropout rate was higher in the extended-release naltrexone arm because patients had to be opioid free for 2 weeks before starting on the opioid antagonist. As a practical matter, that can be difficult to achieve unless a patient has just been released from jail or prison. But the per-protocol relapse rates were similar (Lancet. 2018 Jan 27;391[10118]:309-18).
“Many people interpret this study as saying, with the right patient who can get into an opioid-free state or, if you inherit an opioid-free state, the choice between extended-release naltrexone and buprenorphine-naloxone may be a bit of a wash in terms of clinical effectiveness, as best we can detect,” Dr. Grossman explained. “That said, they’re very different experiences: One is a shot in your butt once a month, the other is something you put in your mouth once a day. Patients typically have a strong point of view regarding what they’re up for.”
Extended-release naltrexone doesn’t require a DEA waiver or attendance at an OTP. But it costs roughly $800 per injection, although many insurers do cover it after additional paperwork is completed. While Dr. Grossman does use extended-release naltrexone in her own practice, it comes with some baggage. The drug comes in a powder, which is mixed with a diluent in the office, creating a thick, frothy substance that’s slow to inject. It has to be kept refrigerated, then warmed up in time for the patient visit.
“If you live somewhere where there’s no OTP and you don’t have a DEA X number, and you have a patient with OUD who’s interested in extended-release naltrexone, it’s not crazy to think about,” she noted.
Duration of medical therapy
Study after study demonstrates that, when treatment stops, the risk of relapse goes up.
“We as health care providers are used to the mentality of chronic diseases, like diabetes, where you’re probably on medicine for the rest of your life,” Dr. Grossman said. “OUD is another chronic disease where you might have a patient on medication for the rest of their life, although you may not want to drum that into their head right up front. It’s kind of scary. I don’t usually talk that way with my diabetic patients when I give them their diagnosis. So, I don’t push it.
“But the reality is, to give them the best chance of health, they should be on medication for a good long time,” she added. “And that’s true for all of the OUD medications.”
The role of counseling
The best evidence of the utility of adjunctive counseling in the treatment of OUD comes from the landmark Prescription Opioid Addiction Treatment Study (POATS), a 653-patient multicenter trial conducted by the National Drug Abuse Treatment Network and funded by the National Institute on Drug Abuse. Participants were randomized to standard medical management including medication and a meeting with a physician every 1-2 weeks, or to standard therapy plus individual counseling with a trained substance use counselor.
To the surprise of many, given that SAMHSA guidance strongly recommends counseling and other forms of behavioral therapy, there was no difference in outcomes between the two groups (Drug Alcohol Depend. 2015 May 1;150:112-9).
Subsequent parsing of the POATS data showed that the subgroup of people who were using heroin rather than prescription pills and who actually attended at least 60% of their counseling sessions did better than if they were randomized to no counseling.
“There’s still room for quibbling about the study, but many people would say, ‘You know, it’s not a slam dunk that everybody needs counseling,’ ” the internist commented.
“So, how do we pick the right treatment for our patients with OUD? It’s what feels right for them,” Dr. Grossman cautioned. “This gets back to what we do every day in managing chronic diseases: We nudge, we encourage, we use our motivational interviewing skills to help people figure out how they can change their lives and get healthier. There’s a long list of things going on in our patients’ lives that are going to help guide that decision.
“The message here: Medication is better than no medication, but it’s not a slam dunk which medication or how,” she concluded.
NEW ORLEANS – Physicians committed to fighting the national opioid epidemic really need to take the 8-hour training course on addiction treatment required to obtain a Drug Enforcement Administration ‘X’ number, because it will enable them to prescribe buprenorphine, a drug with unique advantages for many affected patients, Ellie Grossman, MD, asserted at the annual meeting of the American College of Physicians.
Buprenorphine (Subutex) is one of the three medications approved for treatment of opioid use disorder (OUD), along with methadone and naltrexone (Revia). And for certain patients, it’s clearly the best choice, according to Dr. Grossman, a general internist at Harvard Medical School, Boston, and the primary care lead for behavioral health integration at the Cambridge (Mass.) Health Alliance.
The DEA X number certification process, which entails obtaining a waiver through SAMHSA – the Substance Abuse and Mental Health Services Administration – is bureaucratic. It’s unpopular with many physicians. But it’s well worth 8 hours of an internist’s time to get the waiver and gain the ability to prescribe buprenorphine.
“The requirement is admittedly clunky, and many people have strong feelings about whether this is a regulation that should exist,” according to Dr. Grossman. “I myself didn’t need to have special training to prescribe methadone, a full opioid agonist that my patients could easily die from. But I did have to undergo an 8-hour training to prescribe buprenorphine, and it’s much harder to die from that drug.”
She addressed which of the three medications for OUD is the best fit in a given patient, the appropriate treatment duration, and the role of adjunctive counseling, which – spoiler alert – has been cast into question by the results of a major government-funded randomized trial.
Dr. Grossman’s overriding message: “You are saving lives by getting people on medication.”
Indeed, studies have shown that patients with OUD who receive no treatment have a sixfold increase in the standardized mortality ratio, compared with the general population. Contrast that with the less than 2-fold increased risk with medication-assisted treatment and roughly a 2.5-fold increased risk when medication is given short term to cover withdrawal and then tapered and discontinued.
Other documented benefits of long-term medication-assisted treatment of patients with OUD as described in a 2014 Cochrane review include reductions in injection drug use, crime days, HIV-related risk behaviors and seroconversion, and improved health and social functioning.
Of note, those well-documented benefits apply only to methadone, a full opioid agonist, and buprenorphine, a partial agonist, because those two drugs have been around long enough to generate long-term outcome data. Naltrexone, which has a completely different mechanism of action – it’s a full opioid antagonist – has not as of yet.
Individualizing medical therapy for OUD
Physicians can’t write a prescription for methadone. The drug must be administered at a certified opioid treatment program, or OTP, otherwise known as a methadone clinic. Those clinics are highly regulated at both the federal and state levels, with lots of minutia involved. Patient counseling and drug screening are required.
In contrast, a physician with a DEA X number can write a prescription for buprenorphine and have a patient fill it at a pharmacy. There is inherently less structure surrounding buprenorphine therapy than that of methadone, Dr. Grossman noted. There are no hard and fast rules about how often a physician has to see the patient or do drug screens or counseling. Buprenorphine is available as once-daily oral sublingual therapy and, more recently, in long-acting injectable and implantable formulations, although Dr. Grossman believes the jury is still out about how these nonoral agents are best utilized.
“I’m often asked, ‘Which is better, methadone or buprenorphine?’ Really, the answer is they’re both pretty darn good,” according to Dr. Grossman.
The Cochrane review concluded that, in the studies that have used real-world dosing – that is, higher doses than in the initial studies – high-dose buprenorphine and high-dose methadone have similar rates of retention in treatment.
“What I tell patients is that a lot hinges on the structure of the treatment delivery system,” Dr. Grossman said. “If it’s methadone, they’re going to the OTP every day. Some people need more structure; they need a set of eyes on them every day. Or if they are at high risk for medication diversion – for example, someone else in their household might want to steal their medications – going to a methadone program gets around that. Also, when somebody has been on methadone in the past and did well on it and wants to go on it again, I’m likely to say, ‘That sounds like a good fit.’”
Buprenorphine is a good option for patients who don’t require close, structured supervision. It has fewer drug interactions than does methadone and is less prone to cause QTc prolongation. Also, it’s a more realistic option for patients who live so far from an OTP that daily attendance is impractical. And ob.gyns increasingly favor buprenorphine, because the problem of neonatal abstinence syndrome is less severe than when mothers are on methadone.
As for extended-release naltrexone (Vivitrol), the pivotal double-blind Russian trial that won FDA approval for treatment of OUD showed a dramatic improvement in opioid-free weeks (Lancet. 2011 Apr 30;377[9776]:1506-13).
More recently, the 24-week, multicenter, open-label X:BOT trial randomized 570 U.S. patients with OUD to once-monthly extended-release naltrexone or daily sublingual buprenorphine-naloxone (Suboxone). The dropout rate was higher in the extended-release naltrexone arm because patients had to be opioid free for 2 weeks before starting on the opioid antagonist. As a practical matter, that can be difficult to achieve unless a patient has just been released from jail or prison. But the per-protocol relapse rates were similar (Lancet. 2018 Jan 27;391[10118]:309-18).
“Many people interpret this study as saying, with the right patient who can get into an opioid-free state or, if you inherit an opioid-free state, the choice between extended-release naltrexone and buprenorphine-naloxone may be a bit of a wash in terms of clinical effectiveness, as best we can detect,” Dr. Grossman explained. “That said, they’re very different experiences: One is a shot in your butt once a month, the other is something you put in your mouth once a day. Patients typically have a strong point of view regarding what they’re up for.”
Extended-release naltrexone doesn’t require a DEA waiver or attendance at an OTP. But it costs roughly $800 per injection, although many insurers do cover it after additional paperwork is completed. While Dr. Grossman does use extended-release naltrexone in her own practice, it comes with some baggage. The drug comes in a powder, which is mixed with a diluent in the office, creating a thick, frothy substance that’s slow to inject. It has to be kept refrigerated, then warmed up in time for the patient visit.
“If you live somewhere where there’s no OTP and you don’t have a DEA X number, and you have a patient with OUD who’s interested in extended-release naltrexone, it’s not crazy to think about,” she noted.
Duration of medical therapy
Study after study demonstrates that, when treatment stops, the risk of relapse goes up.
“We as health care providers are used to the mentality of chronic diseases, like diabetes, where you’re probably on medicine for the rest of your life,” Dr. Grossman said. “OUD is another chronic disease where you might have a patient on medication for the rest of their life, although you may not want to drum that into their head right up front. It’s kind of scary. I don’t usually talk that way with my diabetic patients when I give them their diagnosis. So, I don’t push it.
“But the reality is, to give them the best chance of health, they should be on medication for a good long time,” she added. “And that’s true for all of the OUD medications.”
The role of counseling
The best evidence of the utility of adjunctive counseling in the treatment of OUD comes from the landmark Prescription Opioid Addiction Treatment Study (POATS), a 653-patient multicenter trial conducted by the National Drug Abuse Treatment Network and funded by the National Institute on Drug Abuse. Participants were randomized to standard medical management including medication and a meeting with a physician every 1-2 weeks, or to standard therapy plus individual counseling with a trained substance use counselor.
To the surprise of many, given that SAMHSA guidance strongly recommends counseling and other forms of behavioral therapy, there was no difference in outcomes between the two groups (Drug Alcohol Depend. 2015 May 1;150:112-9).
Subsequent parsing of the POATS data showed that the subgroup of people who were using heroin rather than prescription pills and who actually attended at least 60% of their counseling sessions did better than if they were randomized to no counseling.
“There’s still room for quibbling about the study, but many people would say, ‘You know, it’s not a slam dunk that everybody needs counseling,’ ” the internist commented.
“So, how do we pick the right treatment for our patients with OUD? It’s what feels right for them,” Dr. Grossman cautioned. “This gets back to what we do every day in managing chronic diseases: We nudge, we encourage, we use our motivational interviewing skills to help people figure out how they can change their lives and get healthier. There’s a long list of things going on in our patients’ lives that are going to help guide that decision.
“The message here: Medication is better than no medication, but it’s not a slam dunk which medication or how,” she concluded.
NEW ORLEANS – Physicians committed to fighting the national opioid epidemic really need to take the 8-hour training course on addiction treatment required to obtain a Drug Enforcement Administration ‘X’ number, because it will enable them to prescribe buprenorphine, a drug with unique advantages for many affected patients, Ellie Grossman, MD, asserted at the annual meeting of the American College of Physicians.
Buprenorphine (Subutex) is one of the three medications approved for treatment of opioid use disorder (OUD), along with methadone and naltrexone (Revia). And for certain patients, it’s clearly the best choice, according to Dr. Grossman, a general internist at Harvard Medical School, Boston, and the primary care lead for behavioral health integration at the Cambridge (Mass.) Health Alliance.
The DEA X number certification process, which entails obtaining a waiver through SAMHSA – the Substance Abuse and Mental Health Services Administration – is bureaucratic. It’s unpopular with many physicians. But it’s well worth 8 hours of an internist’s time to get the waiver and gain the ability to prescribe buprenorphine.
“The requirement is admittedly clunky, and many people have strong feelings about whether this is a regulation that should exist,” according to Dr. Grossman. “I myself didn’t need to have special training to prescribe methadone, a full opioid agonist that my patients could easily die from. But I did have to undergo an 8-hour training to prescribe buprenorphine, and it’s much harder to die from that drug.”
She addressed which of the three medications for OUD is the best fit in a given patient, the appropriate treatment duration, and the role of adjunctive counseling, which – spoiler alert – has been cast into question by the results of a major government-funded randomized trial.
Dr. Grossman’s overriding message: “You are saving lives by getting people on medication.”
Indeed, studies have shown that patients with OUD who receive no treatment have a sixfold increase in the standardized mortality ratio, compared with the general population. Contrast that with the less than 2-fold increased risk with medication-assisted treatment and roughly a 2.5-fold increased risk when medication is given short term to cover withdrawal and then tapered and discontinued.
Other documented benefits of long-term medication-assisted treatment of patients with OUD as described in a 2014 Cochrane review include reductions in injection drug use, crime days, HIV-related risk behaviors and seroconversion, and improved health and social functioning.
Of note, those well-documented benefits apply only to methadone, a full opioid agonist, and buprenorphine, a partial agonist, because those two drugs have been around long enough to generate long-term outcome data. Naltrexone, which has a completely different mechanism of action – it’s a full opioid antagonist – has not as of yet.
Individualizing medical therapy for OUD
Physicians can’t write a prescription for methadone. The drug must be administered at a certified opioid treatment program, or OTP, otherwise known as a methadone clinic. Those clinics are highly regulated at both the federal and state levels, with lots of minutia involved. Patient counseling and drug screening are required.
In contrast, a physician with a DEA X number can write a prescription for buprenorphine and have a patient fill it at a pharmacy. There is inherently less structure surrounding buprenorphine therapy than that of methadone, Dr. Grossman noted. There are no hard and fast rules about how often a physician has to see the patient or do drug screens or counseling. Buprenorphine is available as once-daily oral sublingual therapy and, more recently, in long-acting injectable and implantable formulations, although Dr. Grossman believes the jury is still out about how these nonoral agents are best utilized.
“I’m often asked, ‘Which is better, methadone or buprenorphine?’ Really, the answer is they’re both pretty darn good,” according to Dr. Grossman.
The Cochrane review concluded that, in the studies that have used real-world dosing – that is, higher doses than in the initial studies – high-dose buprenorphine and high-dose methadone have similar rates of retention in treatment.
“What I tell patients is that a lot hinges on the structure of the treatment delivery system,” Dr. Grossman said. “If it’s methadone, they’re going to the OTP every day. Some people need more structure; they need a set of eyes on them every day. Or if they are at high risk for medication diversion – for example, someone else in their household might want to steal their medications – going to a methadone program gets around that. Also, when somebody has been on methadone in the past and did well on it and wants to go on it again, I’m likely to say, ‘That sounds like a good fit.’”
Buprenorphine is a good option for patients who don’t require close, structured supervision. It has fewer drug interactions than does methadone and is less prone to cause QTc prolongation. Also, it’s a more realistic option for patients who live so far from an OTP that daily attendance is impractical. And ob.gyns increasingly favor buprenorphine, because the problem of neonatal abstinence syndrome is less severe than when mothers are on methadone.
As for extended-release naltrexone (Vivitrol), the pivotal double-blind Russian trial that won FDA approval for treatment of OUD showed a dramatic improvement in opioid-free weeks (Lancet. 2011 Apr 30;377[9776]:1506-13).
More recently, the 24-week, multicenter, open-label X:BOT trial randomized 570 U.S. patients with OUD to once-monthly extended-release naltrexone or daily sublingual buprenorphine-naloxone (Suboxone). The dropout rate was higher in the extended-release naltrexone arm because patients had to be opioid free for 2 weeks before starting on the opioid antagonist. As a practical matter, that can be difficult to achieve unless a patient has just been released from jail or prison. But the per-protocol relapse rates were similar (Lancet. 2018 Jan 27;391[10118]:309-18).
“Many people interpret this study as saying, with the right patient who can get into an opioid-free state or, if you inherit an opioid-free state, the choice between extended-release naltrexone and buprenorphine-naloxone may be a bit of a wash in terms of clinical effectiveness, as best we can detect,” Dr. Grossman explained. “That said, they’re very different experiences: One is a shot in your butt once a month, the other is something you put in your mouth once a day. Patients typically have a strong point of view regarding what they’re up for.”
Extended-release naltrexone doesn’t require a DEA waiver or attendance at an OTP. But it costs roughly $800 per injection, although many insurers do cover it after additional paperwork is completed. While Dr. Grossman does use extended-release naltrexone in her own practice, it comes with some baggage. The drug comes in a powder, which is mixed with a diluent in the office, creating a thick, frothy substance that’s slow to inject. It has to be kept refrigerated, then warmed up in time for the patient visit.
“If you live somewhere where there’s no OTP and you don’t have a DEA X number, and you have a patient with OUD who’s interested in extended-release naltrexone, it’s not crazy to think about,” she noted.
Duration of medical therapy
Study after study demonstrates that, when treatment stops, the risk of relapse goes up.
“We as health care providers are used to the mentality of chronic diseases, like diabetes, where you’re probably on medicine for the rest of your life,” Dr. Grossman said. “OUD is another chronic disease where you might have a patient on medication for the rest of their life, although you may not want to drum that into their head right up front. It’s kind of scary. I don’t usually talk that way with my diabetic patients when I give them their diagnosis. So, I don’t push it.
“But the reality is, to give them the best chance of health, they should be on medication for a good long time,” she added. “And that’s true for all of the OUD medications.”
The role of counseling
The best evidence of the utility of adjunctive counseling in the treatment of OUD comes from the landmark Prescription Opioid Addiction Treatment Study (POATS), a 653-patient multicenter trial conducted by the National Drug Abuse Treatment Network and funded by the National Institute on Drug Abuse. Participants were randomized to standard medical management including medication and a meeting with a physician every 1-2 weeks, or to standard therapy plus individual counseling with a trained substance use counselor.
To the surprise of many, given that SAMHSA guidance strongly recommends counseling and other forms of behavioral therapy, there was no difference in outcomes between the two groups (Drug Alcohol Depend. 2015 May 1;150:112-9).
Subsequent parsing of the POATS data showed that the subgroup of people who were using heroin rather than prescription pills and who actually attended at least 60% of their counseling sessions did better than if they were randomized to no counseling.
“There’s still room for quibbling about the study, but many people would say, ‘You know, it’s not a slam dunk that everybody needs counseling,’ ” the internist commented.
“So, how do we pick the right treatment for our patients with OUD? It’s what feels right for them,” Dr. Grossman cautioned. “This gets back to what we do every day in managing chronic diseases: We nudge, we encourage, we use our motivational interviewing skills to help people figure out how they can change their lives and get healthier. There’s a long list of things going on in our patients’ lives that are going to help guide that decision.
“The message here: Medication is better than no medication, but it’s not a slam dunk which medication or how,” she concluded.
REPORTING FROM ACP INTERNAL MEDICINE