CATR: We often hear about an intervention called medical management (MM) for treating addiction. Could you tell us what MM is?
Dr. Saxon: To set the stage for understanding medical management, we need to go back about 20 years to the inception of the landmark COMBINE Study. This study was a very large clinical trial for alcohol use disorder (AUD) that compared naltrexone, acamprosate, and their combination, and also looked at two behavioral interventions. One of these interventions was MM, and the other was a very robust form of psychotherapy that included elements of motivational interviewing, cognitive behavioral therapy (CBT), and other skills building (Anton RF et al, JAMA 2006;295(17):2003-2017). MM was specifically developed for the COMBINE study.

CATR: Interesting. What was the “active ingredient” in MM?
Dr. Saxon: The idea was that MM would approximate what could be done in primary care by a healthcare provider while also prescribing a medication for AUD, but without the need to be a trained psychotherapist. MM simply involved monitoring the patient and taking vital signs, talking about medication adherence, talking about alcohol use, providing support and, very importantly, reinforcing any positive steps the patient was making. It also included encouraging mutual-help group attendance.

CATR: So, how did MM fare in this comparison?
Dr. Saxon: Well, the punch line is that in this study if you got a pill and you got MM, there was no advantage to adding on the more robust psychotherapy. So that was a strong encouragement that the healthcare provider working with a patient with a substance use disorder (SUD) and prescribing medication could achieve good results without extensive additional treatment.

CATR: These are encouraging results. Can MM also be used for opioid use disorder (OUD)?
Dr. Saxon: Yes, David Fiellin and his colleagues at Yale adapted MM for OUD. The sessions include a few extra things like checking urine toxicology and monitoring psychiatric and medical issues. But it’s basically the same idea: You check in with the patient; make sure the medication is being taken, problem solve if it’s not, find out about the substance use, help the patient to come up with a brief plan for reducing or discontinuing the substance use, and encourage attending a mutual-help group.

CATR: I’ve heard that the easy way to remember MM is to think of it as the four A’s: Abstinence, Adherence, and AA attendance.
Dr. Saxon: Yes, that’s a perfect framework to present it.

CATR: To simplify it even further, one can ask, “What’s so special about doing that? Wouldn’t we do something very similar in treating diabetes or depression or any chronic condition?”
Dr. Saxon: That’s exactly right. It’s sort of that ideal physician visit that’s going to take 15 or 20 minutes, in most cases, and cover all that territory. I think we have always underestimated how meaningful that is to patients to have that time with their healthcare provider.

CATR: That sounds like a good pharmacotherapy visit to me. I’m wondering, though—why do we even have to have a special name for it by calling it MM?
Dr. Saxon: You could call it whatever you want, but you know what happens: When something gets a name, it’s very hard to change that name. We don’t need to call it MM, but that’s what people know it as.

CATR: Seems practical and pretty straightforward. So, we don’t have to refer patients to specialty addiction care?
Dr. Saxon: Not necessarily. It’s similar to what healthcare providers would do when treating any chronic condition. If we think about the opioid crisis and the millions of people who need help, even if the patients were willing to go to specialty programs, there is not enough space to treat everyone. We have to treat them in non-specialty settings. And MM becomes the tool to achieve that.

CATR: What are your thoughts on enhancing MM with other psychosocial interventions for OUD?
Dr. Saxon: A few studies have been done comparing MM alone and MM combined with various psychosocial interventions, such as drug counseling, CBT, and contingency management (Ling W et al, Addiction 2013;108(10):1788–1798). None of these interventions improved on the effectiveness of basic MM. But before concluding that we shouldn’t offer therapy to these patients, we have to realize that these are aggregate results—thus, some people could have had a good response to the added psychotherapy. Besides, often the more challenging patients don’t get into these studies. So we are talking about the average patient in the average office setting who is probably going to do just fine with MM and medication without anything more elaborate, but there could still be some patients who would benefit from more.

CATR: How do you decide who might benefit from more than just office-based meds plus MM?
Dr. Saxon: You just have to make a clinical judgment; if the patient is doing great with MM, why use up precious healthcare resources adding something that’s unnecessary? But if the patient is unstable and struggling, then we have to start looking for other interventions to try and get that patient on track. The idea is to start with the simplest, least costly, and most direct intervention. In most cases, that is office-based buprenorphine, or for some patients it might be extended release naltrexone. For the patients who respond well to that, you’ve found the treatment modality for them. For the patients who are not doing well, you can step up the level of care.

CATR: Let’s talk about OUD meds for a bit. Do you reserve buprenorphine, methadone, and extended release naltrexone for patients in the moderate to severe range of OUD? Or do you intervene even with the mild OUD when only 2 or 3 DSM-5 criteria are met?
Dr. Saxon: I may have a skewed perspective, but in my experience there are very few patients who come to clinical attention who have mild OUD. But I would treat all forms of OUD with medication. It would be a conversation with the patient who has mild OUD, and I would generally recommended extended release naltrexone for those people, presuming that their ability to withdraw from opioids would not be much of a challenge. And if they have substantial withdrawal and have a hard time stopping the opioids, then they are probably going to move at least into the moderate range. So, I think for mild OUD, extended release naltrexone would be my preference.

CATR: What if the patient says, “No, I really don’t want naltrexone; I prefer buprenorphine.”
Dr. Saxon: You have to take it on a case-by-case basis, but I think that would probably be okay, because even with a mild form of the disorder there is still a risk for overdose and inadvertent death if the patient is using opioids, so it’s better to be on the medication.

CATR: On the flipside, can people who do well on buprenorphine for a while be switched to extended release naltrexone?
Dr. Saxon: I wouldn’t do that unless it was at the patient’s request, because if they are doing well on their regimen, I’m not going to rock the boat. But there may be some patients who want to switch, and then that can be a good idea. And if they go on extended release naltrexone and are not doing well, they can always go back to the buprenorphine.

CATR: What about completely detoxing patients off opioids? The FDA recently approved lofexidine for that purpose.
Dr. Saxon: Unfortunately, while complete detox sounds compelling intuitively, it rarely works. Patients with OUD are at very high risk for relapse and overdose if you try to detox them and treat them with behavioral intervention and no medication. This is the treatment that the vast majority of patients with OUD get in our country, and it’s not evidence-based. The only reason for withdrawing patients from opioids is if they want to get on extended release naltrexone. So there’s a real role for lofexidine in helping to make that transition from opioid use to extended release naltrexone—that transition is very difficult, and a large proportion of the patients who attempt withdrawal don’t successfully navigate it. So maybe lofexidine (or its close relative, clonidine) can help with our success there, but again, don’t do it unless the patient wants to go on extended release naltrexone, because if the plan is to go on buprenorphine or methadone, you don’t need to completely withdraw people.

CATR: We hear a lot about rehabs that do not accept patients on OUD meds. What are your thoughts on that?
Dr. Saxon: I think most Americans think if you have an addiction problem, you go to a 28-day program and go drug-free. And of course, these programs are in competition with buprenorphine and methadone clinics. In fact, most people don’t need the 28-day programs, though some of them can be helpful if they accept people on methadone or buprenorphine.

CATR: Some would say that being on a medication for OUD doesn’t mean that the person will necessarily completely stop using, but that at least the person is using less, and we can work on harm reduction strategies (see the Q&A “Naloxone and the Harm Reduction Approach” in the March/April 2016 CATR). Can that be done as part of MM?
Dr. Saxon: Yes, that can be part of MM. If a patient is coming to appointments and still using opioids or other drugs, but is trying to get better, then you should keep working with the patient. Often the problem is that we’ve got these good treatments, but people drop out because we put too many demands on them or perhaps because they can’t afford the medication. We know that if people stay on medication, they are less likely to die, so we want to keep people on it. We also want to make sure that all patients with OUD get prescribed naloxone and, ideally, that their family members receive education on using it. Syringe exchange programs aren’t widely available, but we should talk to patients who inject about where they can get clean needles and syringes. I think that is a great harm reduction tool to help preserve health and limit the spread of infectious diseases.

CATR: Any additional thoughts on providing meds in the context of MM for treating OUD?
Dr. Saxon: I want to emphasize that medication treatment is the treatment for OUD. It’s very important to remain in treatment because when people with OUD leave treatment, they are at very high risk for overdose and death. A lot of providers feel that the ultimate goal is to taper people off medication, and we need to reeducate them that the goal is to keep people on medication, not to get them off. So if you are doing MM with patients on buprenorphine and they’ve been on it for several years, and their lives are going well, and they have good functional status, you want to keep it going; you don’t want to stop the medication. And if you achieve that, you have real treatment success that you can feel very good about.

CATR: Thank you for your time, Dr. Saxon.