Medication-Assisted Treatment for Opioid Addiction: What Is it Really?

Re-clarifying Important Terminology

Now more than ever, the United States is experiencing a pressing need to address the opioid epidemic. Before discussing this and outlining what can and should be done to help people with opioid addiction, a clarification of terms is necessary. In talking about what is happening with opioids, the popular press and social media channels use many buzzwords, one of which is "opioid epidemic" itself. There are several facets to classifying this as an "epidemic" that are important to address: 1) the number of people who use heroin and/or fentanyl has dramatically increased over the last few years; 2) people's misuse of prescription opioids like hydrocodone (Vicodin) and oxycodone (OxyContin) has also greatly increased; 3) more people than ever are becoming addicted to opioids; and 4) an alarming number of people are dying from opioid overdoses (Center for Behavioral Health Statistics and Quality, 2015; Rudd et al., 2016). The increasing trend in opioid overdose deaths is depicted in below.

These aspects of the epidemic have led a number of health care organizations and health-related government agencies to focus on two key areas: how to prevent misuse of opioids in the first place, and how to effectively treat opioid addiction once it occurs. The federal government is addressing these areas with some clear tactics, including the recently-formed Commission on Combatting Drug Addiction and the Opioid Crisis as well as the allocation of billions of dollars to fight the epidemic over the next few years. The 21st Century Cures Act, signed into law by former president Barack Obama in late 2016, gave the Substance Abuse and Mental Health Services Administration (SAMHSA) hundreds of millions of dollars over the next two years to allocate via state-targeted response (STR) grants. As I write this paper, single state agencies typically departments of human services) are figuring out how to award these funds to organizations that want to address the epidemic.

SAMHSA's announcement of the Cures funding focuses on many activities, one of which is medication-assisted treatment (MAT) for the treatment of opioid use disorders (OUD). MAT has become another buzzword, and a great deal of confusion exists about what the approach actually entails. The components of the term are perfectly descriptive and intentional. The "medication" part refers to the use of three FDA-approved medications to treat OUD: buprenorphine, naltrexone and methadone. The medications differ in terms of their effect on the brain and the challenges they address. An important piece that is not widely understood is that medications are only part of a MAT approach. In true medication-assisted treatment, the medications are "assisting" other components of treatment. These components include a variety of psychosocial approaches that address the non-biological aspects of OUD, including a person's behavior, emotions, thought processes, and interactions within social environments (The PEW Charitable Trusts, 2016; SAMHSA, 2016a).

These are important points to keep in mind, because it is easy to confuse the use of medications with MAT itself. A recent blog on an alcohol/drug treatment center website discusses the advantages and disadvantages of MAT, yet nearly all of the content focuses on methadone and Suboxone. The author briefly mentions the importance of counseling in a single sentence and describes it apart from medications, stating "medication-assisted treatment does not address emotional or traumatic issues that may have led to substance abuse" (http://www.pathwaysfl.org/blog/pros-and-cons-of-medicationassisted-treatment). Similarly, another treatment center blog on MAT only refers to the use of Suboxone and methadone, and doesn't mention any psychosocial approaches (http://www.thewellrecoverycenter.com/advantages-and-disadvantagesof-suboxone-and-methadone-for-treating-opioid-addiction/). The use of evidence-based psychosocial approaches alongside the medications (i.e., in concert with them) is often not acknowledged. Given the significance of MAT and the fact that it is becoming part of the national dialogue and strategy around how to address opioid addiction, it is important to understand and communicate about the approach accurately.

The Psychosocial Aspects of MAT

The psychosocial therapies included as part of a medication-assisted treatment approach to opioid use disorder differ, depending on the needs of the client, their challenges and clinical severity, and the type of provider administering the services (e.g., an addiction treatment provider vs. a primary care doctor). To increase the benefit that patients receive from these approaches, they should be evidence-based. The term "evidence-based" is another widely misunderstood term. An evidence-based practice refers to a practice that has been heavily studied by researchers in well-designed scientific studies. These studies should be structured in such a way that the effect of the practice of interest (e.g., cognitive-behavioral therapy) can be clearly measured, typically by comparing a group of patients who receive the intervention with a group who do not receive it. When an intervention has been found to positively impact patients across a number of studies involving different patient groups, it qualifies as evidence-based.

Table 1 provides a brief overview of some commonly used evidence-based approaches for the treatment of substance use disorders. These therapies range from a focus on the patient’s motivation to change their substance use behaviors, to helping them see inaccuracies in how they process information about their environment, to increasing their understanding of spirituality and stressing the importance of Twelve Step meeting attendance as supporting recovery. Any of these approaches can be included in MAT for the treatment of OUD.

Table 1: Commonly-used psychosocial evidence-based practices for treatment of substance abuse disorders

Efficacy of MAT for OUD

Rather than discuss the efficacy of medication-assisted treatment in general for helping individuals with opioid use disorders, which has been well-established (The PEW Charitable Trusts, 2016; U.S. Dept. of Health and Human Services, 2016), in this section I address the issue of whether the psychosocial treatment aspect of MAT is important. As more physicians in primary care settings are trained in prescribing buprenorphine for patients, office-based opioid treatment (OBOT) is increasing (LaBelle et al., 2016). The approach typically used by physicians in this setting is called medication management, which focuses on prescribing information and educating the patient about the drug, its effects, the importance of compliance, and similar issues (Weiss et al., 2011; Fiellin et al., 2013). Ideally, these sessions also include a brief counseling component, but it is unclear to what extent this happens at each medication visit. In some cases, it seems unlikely that these counseling sessions are occurring, given that physicians report increasing pressures to see more patients and spend less time with them per visit (Rabin, 2014; Dugosh et al. 2016). What is clear is that the counseling sessions conducted via medication management in primary care settings are different than sessions conducted by mental health professionals in both length and content (Weiss et al., 2010).

The evidence that opioid agonist medications like buprenorphine help people with opioid use problems is also quite solid at this point. Study findings converge on the conclusion that these medications are effective in controlling cravings, easing withdrawal and reducing opioid use American Society of Addiction Medicine, 2013). There is also some evidence that the psychosocial aspects of MAT are important, but the research is somewhat mixed: some studies have found that psychosocial treatments increase positive outcomes above and beyond meds alone, whereas some have found no differences. In a recent review of this topic, Dugosh et al. (2016) summarize the results of three literature reviews and 27 empirical studies. Among 14 studies examining methadone maintenance, 12 (86%) showed better outcomes for patients who received a psychosocial intervention along with methadone as compared to methadone alone. Psychosocial therapies included cognitive-behavioral therapy (CBT), contingency management and general supportive counseling. Patient outcomes were measured by treatment retention, opioid use and medication compliance.

Of eight studies involving buprenorphine, three (38%) showed an incremental effect of the psychosocial intervention (therapies included CBT, community reinforcement and family training, and intensive role induction). These findings are not as strong as for methadone maintenance, in that over half of the studies found no effect of psychotherapy beyond the medications. Details of some studies are shown in Table 2. A closer inspection of study methodologies reveals some interesting patterns. First, nearly all of these studies were conducted on patients presenting to primary care settings. Second, certain patients were excluded from participating based on clinical severity, including suicide risk, active dependence on alcohol and/or sedatives, poor physical health, past trauma and mental health issues like depressive disorders (Fiellin et al., 2013; Weiss et al., 2011; Moore et al., 2012). The characteristics of participants in these studies are not realistic in most clinical settings, where people with multiple problems and co-morbidities are seeking care (Hser et al., 2017). To the extent that patients higher in clinical severity are most likely to benefit from psychosocial approaches, the relatively low patient acuity in these studies might help explain why the psychosocial therapies did not have an effect beyond the medications.

Table 2: Buprenorphine studies that showed no incremental effect of psychosocial therapies on patient outcomes

Another way to make sense of the null buprenorphine study findings pertains to how well the intervention was delivered and how engaged the patient was in the therapeutic process. Regarding delivery, the therapist or practitioner administering the intervention needs to follow the treatment protocol consistently across patients and across sessions. This is called fidelity of implementation. Regarding engagement, in order for patients to get the most benefit from the intervention, they need to show up to all sessions over the course of treatment (Joe et al., 1999; Ledgerwood et al., 2008). If either or both of these things don't happen, one could expect to find little to no impact of psychosocial therapy on outcomes. Weiss et al. (2011) point out that in the prescription opioid addiction treatment study (POATS), patients in the medication plus counseling group were much more likely to miss counseling appointments than medication appointments. Fiellin et al. (2013) also reported low CBT session attendance, where patients attended an average of 6.7 of 12 sessions (56% of the time). Patients in the CBT condition were also significantly more likely to miss their medication sessions than medication-only patients. This is not surprising, given that attendance at CBT sessions was optional in the study. These findings illustrate why treatment adherence and engagement are so important for patients with opioid use disorder. If adherence had been higher in the CBT groups, CBT might have had more of an impact on outcomes. Notably, in a study using similar methodology, Moore et al. (2012) reported that the greater the number of CBT sessions people attended, the more likely they were to achieve abstinence from opioids.

Clearly, more research is needed to determine which combination of MAT medications (especially buprenorphine) and psychosocial therapies work best for which types of patients. It is possible that patients lower in clinical severity may fare well with medication management, and counseling is not going to create much more difference on outcomes. In contrast, patients with higher clinical severity are likely to benefit from medication and counseling (i.e., medication-assisted treatment), particularly intensive counseling using an evidence-based model. This is consistent with what we know about the treatment of substance abuse disorders (SUD) overall (SAMHSA, 2016b). Future studies need to recruit clinically severe samples of patients with opioid use disorder from a variety of care settings, and examine how different components of MAT impact outcomes.

The Hazelden Betty Ford Foundation's Comprehensive Opioid Response with the Twelve Steps™ (COR-12)

Many discussions of medication-assisted treatment for opioid use disorder assume that the use of opioid agonists like methadone and buprenorphine is separate from formal addiction treatment, particularly programs that stress the importance of abstinence. For example, a piece aired last year on NPR's All Things Considered talked about inpatient addiction treatment as one alternative, and the use of opioid agonists like buprenorphine as another. The two types of treatment are discussed as separate approaches instead of one integrated approach. Michael Botticelli, director of National Drug Control Policy at the time, is quoted as saying: "I've seen people with opioid-use disorders go through inpatient treatment without medications time and time again, without ever being offered alternatives." The piece also points out that despite what science is telling us, many people "stand by the so-called abstinence route—recovery without the use of medications." (http://www.npr.org/sections/healthshots/2016/05/17/478387232/treating-opioid-addictionwith-a-drug-raises-hope-and-controversy).

In early 2013, the Hazelden Betty Ford Foundation acknowledged an urgent need to be doing more for patients with opioid addiction. Patients admitted to the Foundation's programs reported extensive past treatment histories, had a large degree of clinical severity in addition to their opioid use, and were leaving treatment prematurely. Most critically, some were overdosing and dying. In response to this, and based on a strong belief that anti-addiction medications have a place in abstinence-based treatment, a cross-disciplinary team of Hazelden Betty Ford staff designed and implemented a MAT model for patients with OUD. The core elements of this model, called Comprehensive Opioid Response with the Twelve Steps (COR-12), are: 1) the use of buprenorphine-naloxone or naltrexone (where appropriate); 2) Twelve Step-based treatment; 3) individual and group counseling sessions; and 4) the use of evidence-based practices in counseling sessions, such as motivational interviewing and CBT. Regarding group counseling, a core part of the program is the use of opioid support groups both during and after treatment. These groups focus on issues and challenges specific to recovering from OUD, including the experiences related to taking buprenorphine or naltrexone as part of treatment and recovery.

Importantly, buprenorphine-naloxone is used with some patients beyond detoxification from opioids. Patients are maintained on buprenorphine not only as part of treatment, but as part of ongoing recovery. In this sense, COR-12 is really a model of medication-assisted recovery (MAR). Because opioid use disorder and other substance use disorders are chronic illnesses that need to be managed over the long term (Dennis & Scott, 2007; McLellan et al., 2000), providing patients with a number of different ways to recover from these disorders after a formal treatment episode is important. Recovery from SUD is a long-term process, and the basis of Hazelden Betty Ford Foundation's COR-12 model is to help patients achieve recovery from OUD with all of the means available to effectively treat these disorders. The use of medications, both during treatment and as a way to support long-term recovery, is a key component of this approach. The Foundation views patients who take buprenorphine in this way as being abstinent and in recovery, just as patients in recovery from SUD would be considered in recovery if they were taking prescription opioids as prescribed by their doctor to treat pain after a major surgery. Each patient's recovery trajectory will be different, and some patients may need to take buprenorphine over an extended period of time. The overall goal is to get the patient well and on a path to long-term recovery with any clinical means that are beneficial for that patient.

Figure 2