Opioid addiction is driving an epidemic of drug overdose deaths. Prescription painkillers accounted for nearly 19,000 overdose deaths in 2014, with more than another 10,000 overdose deaths related to heroin use. Historically, treatment outcomes for opioid use disorder have been poor. Treatment needed to evolve to meet the needs of this crisis. The Hazelden Betty Ford Foundation formed a cross-disciplinary team of medical, clinical, research, administrative, and communications professionals to research, study, and implement solutions to the opioid problem. The result of this effort was the development of the innovative Comprehensive Opioid Response with the Twelve Steps (COR-12®) program. This Q-and-A with Dr. Audrey Klein, a leading research scientist, and Cathy Stone, COR-12 program manager at Hazelden Betty Ford in St. Paul and one of the team members who developed the program, explores how this evidence-based, medication-assisted treatment program works and how well it is working. This program is designed to treat those addicted to both prescription drugs and illegal opioids. How many prescriptions were being written for opioids before it became apparent they were such a problem for people? Dr. Klein: In 2012, 259 million prescriptions were written for opioids. To contextualize this, that's enough to give every American adult their own bottle of pills. Since 1999, the amount of prescription opioids sold and distributed in the US has nearly quadrupled. The amount of pain that Americans are reporting—including chronic pain—has not increased anywhere near the rate in the increase of opioid prescriptions. There is clearly a relationship between the increase in the rate of these prescriptions and the issues we're seeing with overdose and abuse of these medications. How common are overdose deaths from opioids? Dr. Klein: Overdose has now surpassed traffic accidents as the number one leading cause of accidental death. In 2014, nearly 19,000 overdose deaths were related to prescription painkillers. Another 10,574 were related to heroin. Those numbers likely underestimate the actual number of deaths due to opioids, since most death certificates don't list the type of drug involved in the overdose. And the epidemic continues to worsen. The number of deaths from illicit opioids like heroin, for example, rose sharply again in 2015 and continued to increase in 2016. According to the CDC, over 33,000 Americans died from an opioid overdose of one kind or another in 2015. Historically, treatment for opioid addiction has not been consistently effective. What has the Hazelden Betty Ford Foundation done to address this growing crisis? Cathy: Our response has included a fully-integrated approach to treating clients with an opioid addiction. We called the program COR-12, Comprehensive Opioid Response with the Twelve Steps. We knew we needed a long-term engagement program that would help clients move from a professional, clinically-managed recovery to a fully self-managed recovery. And it needed to be a program that worked in line with our philosophies and our ideologies. We wanted to use evidence-based practices and therapies, and a growing body of research indicates the medication-assisted therapies (MATs) may be the most effective in treating opioid addiction. We're also a 12-step based treatment program, and we wanted to figure out how to incorporate the work that we do from a therapeutic standpoint with medication-assisted therapy. Was the Hazelden Betty Ford Foundation hesitant to participate in medication-assisted addiction treatment? Cathy: Initially, we had to think about how the medication-assisted therapies would be perceived both internally within the organization, as well as externally. We knew that some people would be cautious about the use of medications to treat opiate addiction. But the research really does show that the use of a medication like Buprenorphine can have a significant impact, not only in ensuring recovery but also in mitigating death. That is of fundamental importance to us. Our goal will always be abstinence. What we tried to help everybody understand is that the use of medication to treat somebody in their addiction is part of abstinence, just as other medications used in medical settings. Many medications can be abused, but when they're part of a treatment protocol they equate to that patient maintaining their abstinence. That's how we feel about the use of this medication for our patients. They are maintaining their abstinence. They are taking something prescribed, something for their health as part of their treatment process. How did you begin to develop and implement this new approach to opioid dependence treatment? Cathy: It became clear that the abuse of opioids was reaching a crisis level. Back in 2001, just 15 percent of the population at our youth facility was in opiate addiction. By 2011, that went up to 41 percent. COR-12 developed over time as a response to this. We initially started to implement COR-12 in late 2012 with just a few clients in our outpatient setting. By 2015, we had more than 120 participants in the program. As it evolved, we learned a lot about how to best treat this population. We were new to the use of Buprenorphine, and we were a little nervous about how it would impact client care. We set very strict parameters and boundaries in how we worked with these clients. Eventually, though, that gave way to a much more client-centered approach. How did the COR-12 opioid treatment evolve? Cathy: This population of people really struggles with executive function skills. Creating a bunch of hurdles for them to jump over in order to use the medication they need to use to stay safe eased our anxieties, but it created a barrier for patients. For example, in order to see this particular provider, you need to see another provider first. If our patients are having a difficult time scheduling and keeping appointments because of their addiction, how do we work with them? How do we identify barriers that they're experiencing in our programming and eliminate them in order to increase engagement and build a sense of positive momentum for them in their recovery process? What we found was that by integrating the medication-assisted therapies more intentionally with the rest of what we do, we became a lot more comfortable with the medication and what it could do for our patients. In our outpatient program, we serve opiate-addicted clients who are over the age of 18. All of our clients have a moderate to severe opiate addiction in which opiates are the drug of choice. The way I usually describe this to patients and families is that when they're sitting in group, I really want those patients to feel like they're with their people. I want them to be with people who they feel like understand their plight as an opiate addict and the issues they uniquely struggle with. What are issues that opiate addicts uniquely struggle with? Cathy: Most of our clients in their 20s tend to be IV heroin users. What we learned about this population is that there is a high correlation between IV drug use and childhood abuse. In addition, we noticed that many of these clients have had some kind of close experience with overdose and death. That told us we needed to look at what research was out there about trauma-informed treatment and how we could create an integrated approach to the care that we provide. So a lot of the work that we do is based in building emotional resiliency and competency. These clients are using a very potent mood-altering substance to numb their emotional experience. Their distress tolerance is often very low at the height of their use. So part of the work that we do is helping them to better understand their emotional world and increase their ability to understand and to articulate what they're experiencing and what they're feeling so that they can intentionally attend to their needs. What are other things you do to serve people with opioid use disorder? Cathy: They're meeting with doctors, therapists, psychiatrists, and with our addiction counseling staff. That's a lot of appointments to manage, especially for clients with compromised executive function. So we created a program that is fully integrated with no external appointments. They come for three hours a day, initially coming five days a week. During those three hours, they'll be scheduled to see their psychiatrist or see their doctor or their therapist or, obviously, to be in their addiction treatment groups. They don't need to remember to be back at our building another day, another time. They will always have their mental health and medical needs addressed on time and prescriptions monitored appropriately. We also learned that creating some kind of a relationship with local twelve-step meetings can be helpful. I always encourage people who are looking at starting a program to identify local groups that are supportive of people being on medication like Suboxone. Some people can be pretty discouraging to those that are on these medications in recovery. In lieu of finding a community, you can always start your own medication-friendly Twelve Step support group, which is one of the things that we've done here, as well. Another indispensable component of the program was reaching out to our local community support for clients who are on opiates. That includes building relationships with local sober-house owners and managers to talk about our programs. We've worked with our local Narcan distribution centers, as well as identifying both Suboxone and Vivitrol providers. It's not uncommon that we'll get a client who will graduate from our program and want to seek additional medication management. We try to do what we can to make sure they get to a provider that can meet that need for them. Also, having a strong relationship with local community mental health providers can be vital. How long do clients stay in the COR-12 program? Cathy: Ours is a long-term engagement program. We have many clients who have been engaged with us for over two years. Our goal is to help clients stay engaged in addiction treatment for at least four months, and I fully expect most patients to stay longer than that. But we've recognized that if we can engage them for three months, their ability to get traction in their recovery significantly increases. Our ultimate goal, of course, is to become unnecessary in a client's recovery. We want to help them get to a place where they're self-managing their recovery, that they have the support of professionals they are using on an outpatient basis or their local Twelve Step community, as well as family and social supports that are substantial enough to help them have a full and satisfying life that doesn't include the use of mood-altering substances. So how effective is COR-12? What results have you seen from the program so far? Dr. Klein: The Butler Center for Research at the Hazelden Betty Ford Foundation has begun to study the outcomes for those who participate in the COR-12 program for treating opioid dependency. The following statistics are pulled from two sources: our large administrative data set, the information we collect in relationship to all of our clients, as well as a continuing study that we have begun specifically to evaluate outcomes for COR-12 patients. Of course, these numbers should be read cautiously. They come from a small sample size of 159 COR-12 clients and from a study that is still underway. Still, the results are encouraging. One outcome we can measure is whether clients remain in a recommended residential treatment program through to its completion. Especially for opioid dependent folks, having them complete a given treatment episode is a very important outcome for their ongoing success in recovery. What we found when comparing our COR-12 participants for the first half of 2016 to all other adults in residential treatment is that COR-12 folks leave early only 6.42 percent of the time. Other folks discharge early 22 percent of the time. That is a significant difference. When contacted about their outcomes at six months after treatment, 71 percent of COR-12 clients had remained abstinent, as compared to 52 percent of non-COR-12 patients. In addition, 74 percent reported their overall quality of life as excellent or very good (compared to 61 percent) and 82 percent reported complying with most or all of their care plan (as compared to 63 percent). Again, however, these encouraging results should be taken with caution, as the data is still being collected. Could the COR-12 opioid treatment model work outside of a Hazelden Betty Ford Foundation location? Dr. Klein: Yes, our opioid addiction treatment model, COR-12, can be implemented in a variety of health care settings that have a need to integrate medication-assisted treatment with psychosocial therapies. A strategic focus of the Hazelden Betty Ford Foundation is just that, to bring COR-12 opioid treatment programming to interested providers who need help with their opioid dependent patients. Our model for bringing these services to other providers consists of several elements, including training of senior executives, in-depth training of front-line clinical and medical staff to deliver evidence-based services, and conducting a fidelity assessment once implementation has occurred. I also personally consult with leaders of organizations on the importance of measuring patient outcomes, and I assess the provider’s readiness to begin outcomes data collection and reporting. In 2016, I worked with several providers in Kentucky, and in 2017 the Hazelden Betty Ford Foundation plans to bring services to more providers across the country.