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Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2005. (Treatment Improvement Protocol (TIP) Series, No. 43.)

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Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs.

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Chapter 1. Introduction

In This Chapter …

Purpose of This TIP

Key Definitions

Audience for This TIP

A Decade of Change

Remaining Challenges

The Future of MAT

Opioid addiction is a problem with high costs to individuals, families, and society. Injection drug use-associated exposure accounts for approximately one-third of all AIDS cases diagnosed in the United States through 2003 (National Center for HIV, STD and TB Prevention 2005) and for many cases of hepatitis C (National Institute on Drug Abuse 2000; Thomas 2001). In the criminal justice system, people who use heroin account for an estimated one-third of the $17 billion spent each year for legal responses to drug-related crime. Indirect costs from lost productivity and overdose also are high (Mark et al. 2001), and people with opioid addictions and their families experience severe reductions in their quality of life. The increasing abuse of prescription opioids is another major concern, both for their damaging effects and as gateway drugs to other substance use (see chapter 2).

Purpose of This TIP

This Treatment Improvement Protocol (TIP) is a guide to medication-assisted treatment for opioid addiction (MAT) in opioid treatment programs (OTPs). Compared with MAT in other settings, such as physicians' offices or detoxification centers, treatment in OTPs provides a more comprehensive, individually tailored program of medication therapy integrated with psychosocial and medical treatment and support services that address most factors affecting each patient. Treatment in OTPs also can include detoxification from illicit opioids and medically supervised withdrawal from maintenance medications.

This TIP combines and updates TIP 1 (State Methadone Treatment Guidelines, published in 1993), TIP 10 (Assessment and Treatment of Cocaine-Abusing Methadone-Maintained Patients, published in 1994), TIP 20 (Matching Treatment to Patient Needs in Opioid Substitution Therapy, published in 1995), and TIP 22 (LAAM in the Treatment of Opiate Addiction, published in 1995). It incorporates the many changes in MAT that have occurred since the publication of TIP 1, primarily as they are reflected in OTPs, and discusses the challenges that remain.

Key Definitions

The glossary (Appendix C) and list of acronyms (Appendix B) at the back of the book provide definitions of key words, terms, acronyms, and abbreviations. Particularly important distinctions among selected terms and phrases are discussed below.

Distinctions between dependence and addiction vary across treatment fields. This TIP uses the term “dependence” to refer to physiological effects of substance abuse and “addiction” for physical dependence on and subjective need and craving for a psychoactive substance either to experience its positive effects or to avoid negative effects associated with withdrawal from that substance.

MAT is any treatment for opioid addiction that includes a medication (e.g., methadone, buprenorphine, levo-alpha acetyl methadol [LAAM], naltrexone) approved by the U.S. Food and Drug Administration (FDA) for opioid addiction detoxification or maintenance treatment. MAT may be provided in an OTP or an OTP medication unit (e.g., pharmacy, physician's office) or, for buprenorphine, a physician's office or other health care setting. Comprehensive maintenance, medical maintenance, interim maintenance, detoxification, and medically supervised withdrawal (defined under “Treatment Options” below and individually in the glossary) are types of MAT.

An OTP is any treatment program certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) in conformance with 42 Code of Federal Regulations (CFR), Part 8, to provide supervised assessment and medication-assisted treatment for patients who are opioid addicted. An OTP can exist in a number of settings, including, but not limited to, intensive outpatient, residential, and hospital settings. Types of treatment can include medical maintenance, medically supervised withdrawal, and detoxification, either with or without various levels of medical, psychosocial, and other types of care.

The term “abstinence” in this TIP refers to nonuse of alcohol or illicit drugs (drugs not approved by FDA), as well as nonabuse of prescription drugs. Abstinence does not refer to withdrawal from legally prescribed maintenance medications for addiction treatment (for which “medically supervised withdrawal” is the preferred term).

Terminology continues to evolve for describing the combination of substance use and mental disorders. In this TIP, “co-occurring” is the preferred term, but others use “coexisting,” “dual diagnosis,” and “comorbid” to describe the combination of current or former substance use disorders and any other Axis I or any Axis II mental disorders recognized by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (American Psychiatric Association 2000). (See also TIP 42, Substance Abuse Treatment for Persons With Co-Occurring Disorders [CSAT 2005b ].)

Audience for This TIP

The intended audience for this TIP is treatment providers and administrators working in OTPs. Other groups that want to understand the principles and procedures followed in MAT also will benefit.

A Decade of Change

Several forces are transforming the MAT field. The implementation of an accreditation system (Federal Register 64:39814) is standardizing and improving opioid addiction treatment (for details, see 42 CFR, Part 8). Choices of medication, including methadone, buprenorphine, LAAM, and naltrexone (see chapter 3), now are available to treat opioid addiction. Each has its own benefits and limitations. Continued research on opioid addiction and treatment is clarifying what works to improve treatment outcomes, with an emphasis on accelerating the incorporation of evidence-based methods into treatment. Changes in the health care system nationwide (e.g., the growth of managed care and effects of the Health Insurance Portability and Accountability Act) are having an effect on OTPs and other types of health care programs. Understanding and acceptance of opioid addiction as a medical disorder by patients, health care providers, the media, and the public have increased since the publication of TIP 1.

MAT—A More Accepted Form of Treatment

Opioid addiction as a medical disorder

Discussions about whether addiction is a medical disorder or a moral problem have a long history. For decades, studies have supported the view that opioid addiction is a medical disorder that can be treated effectively with medications administered under conditions consistent with their pharmacological efficacy, when treatment includes comprehensive services, such as psychosocial counseling, treatment for co-occurring disorders, medical services, vocational rehabilitation services, and case management services (e.g., Dole and Nyswander 1967; McLellan et al. 1993).

Dole (1988, p. 3025) described the medical basis of methadone maintenance as follows:

The treatment is corrective, normalizing neurological and endocrinologic processes in patients whose endogenous ligand-receptor function has been deranged by long-term use of powerful narcotic drugs. Why some persons who are exposed to narcotics are more susceptible than others to this derangement and whether long-term addicts can recover normal function without maintenance therapy are questions for the future. At present, the most that can be said is that there seems to be a specific neurological basis for the compulsive use of heroin by addicts and that methadone taken in optimal doses can correct the disorder.

Similarities to other medical disorders

McLellan and colleagues (2000) compared basic aspects of substance addiction with those of three disorders—asthma, hypertension, and diabetes—which universally are considered “medical” and usually chronic and relapsing and for which behavioral change is an important part of treatment. They found that genetic, personal-choice, and environmental factors played comparable roles in the etiology and course for these disorders and that rates of relapse and adherence to medication were similar, although substance addiction often was treated as an acute, not chronic, illness. Their review of outcome literature showed that, as with the other disorders, substance addiction has no reliable cure but that patients who comply with treatment regimens have more favorable outcomes. Fewer than 30 percent of patients with asthma, hypertension, or diabetes adhered to their medication regimens, prescribed diets, or other changes to increase their functional status and reduce their risk of symptom recurrence. As a result, 50 to 70 percent experienced recurrent symptoms each year to the point of requiring additional medical care to reestablish remission.

Another similarity found between opioid addiction and these medical disorders was their outcome predictors (McLellan et al. 2000). For example, patients who were older and employed with stable families and marriages were found to be more likely to comply with treatment and have positive treatment results than were younger, unemployed patients with less stable family support.

The concept of opioid addiction as a medical disorder was supported further by other treatment followup studies showing that opioid addiction has a reasonably predictable course, similar to such conditions as diabetes, hypertension, and asthma. For example, Woody and Cacciola (1994) found that the risk of relapse for a person who was opioid addicted was highest during the first 3 to 6 months after cessation of opioid use. This risk declined for the first 12 months after cessation and continued to decrease but at a much slower rate. Results from other posttreatment studies indicated that roughly 80 percent of patients who are opioid addicted but leave MAT resume daily opioid use within 1 year after leaving treatment (e.g., Magura and Rosenblum 2001).

Similar to patients with other chronic disorders, many who are opioid addicted have been found to respond best to treatment that combines pharmacological and behavioral interventions. As detailed throughout this TIP, treatment of opioid addiction with maintenance medication, along with other treatment services for related problems that affect patients' motivation and treatment compliance, increases the likelihood of cessation of opioid abuse. Conversely, discontinuation of maintenance medication often results in dropout from other services and a return to previous levels of opioid abuse, with its accompanying adverse medical and psychosocial consequences (Ball and Ross 1991). Entry into comprehensive maintenance treatment provides an opportunity to prevent, screen for, and treat diseases such as HIV/AIDS, hepatitis B and C, and tuberculosis (see chapter 10) and to increase compliance with medical, psychiatric, and prenatal care (Chaulk et al. 1995; Umbricht-Schneiter et al. 1994). Recent data on buprenorphine indicate that treatment with this medication, like methadone, has similar positive outcomes (CSAT 2004a ; Johnson et al. 2000; Kakko et al. 2003).

Viewing opioid addiction as a medical disorder is consistent with the idea that treatment of even severe cases improves outcomes, just as in other chronic and relapsing medical disorders, even before abstinence is achieved. For example, Metzger and colleagues (1998) found that substance abuse treatment was associated with a significantly lower risk of HIV infection than was nontreatment. Treatment also was associated with a significant reduction, but not necessarily cessation, of drug use for many individuals. Similar findings on the positive health outcomes associated with maintenance treatment of opioid addiction, regardless of whether abstinence was attained, were seen in studies finding that methadone maintenance decreases overdose death. Data on benefits of partial responses to maintenance treatment resemble the benefits of treatment for other chronic medical disorders in terms of symptom alleviation. An analogy with MAT would be the desirability of reducing the risk of HIV infection, overdose, and the many psychosocial complications of addiction, which is not as desirable as the benefits of attaining complete abstinence from opioids but is associated with significantly improved patient health and well-being. The goal is always reducing or eliminating the use of illicit opioids and other illicit drugs and the problematic use of prescription drugs.

The medical community recognizes that opioid addiction is a chronic medical disorder that can be treated effectively with a combination of medication and psychosocial services. An important development in MAT during the 1990s was the 1997 publication of recommendations by a National Institutes of Health consensus panel on effective medical treatment of opiate addiction. After hearing from experts and the public and examining the literature, the panel concluded that “[opioid addiction] is a medical disorder that can be effectively treated with significant benefits for the patient and society” (National Institutes of Health 1997b , p. 18). That panel explicitly rejected the notion “that [addiction] is self-induced or a failure of willpower and that efforts to treat it inevitably fail” (p. 18). It called for “a commitment to offer effective treatment for [opioid addiction] to all who need it” (p. 2). The panel also called for Federal and State efforts to reduce the stigma attached to MAT and to expand MAT through increased funding, less restrictive regulation, and efforts to make treatment available in all States (p. 24). The consensus panel for this TIP further recommends that access to treatment with methadone and other FDA-approved medications for opioid addiction be increased for people who are incarcerated, on parole, or on probation.

The trend toward greater acceptance of MAT as an effective treatment for opioid addiction has resulted in fewer State-mandated restrictions for treatment. For example, many States have removed restrictions on the length of time that patients may remain in treatment.

More Treatment Programs and More Patients in Treatment

In 1993, when TIP 1 was published, approximately 750 registered OTPs were treating some 115,000 patients in 40 States, the District of Columbia, Puerto Rico, and the Virgin Islands (CSAT 1993b , p. 1). At this writing, more than 1,100 OTPs operating in 44 States, the District of Columbia, Puerto Rico, and the Virgin Islands are treating more than 200,000 patients (Substance Abuse and Mental Health Services Administration n.d.b ; Nicholas Reuter, personal communication, June 2004). As of this writing, methadone treatment is not available in six States: Idaho, Mississippi, Montana, North Dakota, South Dakota, and Wyoming.

Most expansion in the treatment system in the past 10 years has occurred in the proprietary sector. Historically, most OTPs were funded publicly, whereas proprietary programs were in the minority. In the 1980s, public funding for methadone treatment began to be reduced, along with State, Federal, and local budgets, and increasingly was replaced by private fee-for-service treatment programs in which patients bore more of the costs (Knight et al. 1996a , 1996b ; Magura and Rosenblum 2001).

Choices of Medications

The National Institute on Drug Abuse (NIDA) has been working to broaden the array of effective treatment medications for chronic opioid addiction. Just after the publication of TIP 1, FDA approved the use of LAAM, although its use has been curtailed substantially since then (see chapter 3). In October 2002, FDA approved two new formulations containing buprenorphine for treatment of opioid addiction. Buprenorphine is used to treat individuals who have been opioid addicted for less than 1 year, as well as patients for whom buprenorphine's unique properties are beneficial (CSAT 2004a ). The opioid antagonist naltrexone is available to treat people who are opioid addicted and have undergone medically supervised withdrawal. These medications are discussed in chapter 3.

Treatment Options

OTPs can provide several treatment options:

  • Maintenance treatment combines pharmacotherapy with a full program of assessment, psychosocial intervention, and support services; it is the approach with the greatest likelihood of long-term success for many patients.
  • Medical maintenance treatment is provided to stabilize patients and may include long-term provision of methadone, buprenorphine, LAAM, or naltrexone, with a reduction in clinic attendance and other services. A patient can receive medical maintenance at an OTP, after he or she is stabilized fully. The patient usually must complete a comprehensive treatment program first. The decision about whether to provide medical maintenance must be made by a licensed practitioner. A designated medication unit (e.g., physician's office, pharmacy, long-term care facility) affiliated with an OTP can provide some medical maintenance services. To reduce clinic attendance—a key feature of medical maintenance—patients must qualify, subject to variations in State regulations (which may be more stringent than Federal regulations), to receive 7- to 14-day supplies of methadone for take-home dosing after 1 year of continuous treatment and 15- to 30-day supplies after 2 years of continuous treatment in an OTP (if additional criteria are satisfied [see chapter 5]) (42 CFR, Part 8 § 12(h); Federal Register 66:4079).
  • Detoxification from short-acting opioids involves medication and, perhaps, counseling or other assistance to stabilize patients who are opioid addicted by withdrawing them in a controlled manner from the illicit opioids.
  • Medically supervised withdrawal treatment involves the controlled tapering of treatment medication for patients who want to remain abstinent from opioids without the assistance of medication.

Based on the framework provided by the Drug Addiction Treatment Act of 2000 (21 United States Code 823(g)), qualified practitioners are authorized to use Subutex® and Suboxone® (see chapter 3) to treat chronic opioid addiction in an office-based opioid treatment (OBOT) or other health care setting.

These alternatives are increasing access to care as OTPs broaden their range of treatment options, more physicians offer OBOT and become better trained in MAT principles and methods, and individuals with opioid addiction seek new points of treatment entry. At this writing, the availability of these options varies, often because of individual State regulations.

Changes in the Federal Regulatory System

On May 18, 2001, SAMHSA promulgated a new accreditation oversight system. Its goal is to “reduce the variability in the quality of opioid treatment services, and reform the treatment system to provide for expanded treatment capacity” (Federal Register 64:39814). As OTPs meet these national standards, treatment improvement is expected to continue along with increased attention to program evaluation and quality improvement mechanisms. The consensus panel hopes that this TIP will contribute to the movement toward quality-driven treatment standards.

Remaining Challenges

Although important strides have been made, much remains to be done to improve and expand treatment and to address the stigma that affects patients and programs.

Administering Appropriate Dose Levels

The consensus panel believes that programs should monitor and adjust patients' dose levels of methadone and other opioid treatment medications to ensure that they receive therapeutic dosages without regard to arbitrary dose-level ceilings that are unsupported by research evidence. Dosage decisions should be appropriate and tailored to each patient. Progress has been made to ensure that patients receive the therapeutic dosage levels they need to remain stabilized; however, the panel finds it troubling that some OTPs still fail to prescribe medication in adequate doses (D'Aunno and Pollack 2002).

Treating Patients Who Have More Complex Problems

Complex problems can complicate patients' diagnosis and treatment. When TIP 1 was published, the opioid addiction treatment system faced two major challenges—the spread of HIV/AIDS and the problem of untreated co-occurring disorders. The consensus panel believes that the provision of psychiatric services at or through OTPs has not kept pace with best practices. It is critical that OTPs be prepared to diagnose and treat co-occurring disorders aggressively, either directly or by referral. This issue is discussed in chapter 12.

The treatment system is grappling with the implications of hepatitis C virus (HCV) infection among people who inject drugs, with estimates of HCV infection in this group ranging from 60 percent on average nationwide (National Institute on Drug Abuse 2000) to 90 percent in some regions (Thomas 2001). OTPs face the challenge of how to provide patient education and HCV testing for people who inject drugs.

Patterns of opioid abuse have changed in the past decade. For example, in some areas of the country, patients are presenting with addiction to pain management medications as a primary admission indication (CSAT 2001a ; Office of National Drug Control Policy 2002). OTPs report that patients addicted to pain management medications require higher therapeutic methadone levels than other patients. Since the mid-1990s, the prevalence of lifetime heroin use has increased for both youth and young adults. From 1995 to 2002, the rate among youth ages 12 to 17 increased from 0.1 to 0.4 percent; among young adults ages 18 to 25, the rate rose from 0.8 to 1.6 percent (Substance Abuse and Mental Health Services Administration 2003c)

Promoting Evidence-Based Treatment Services

Throughout this TIP are many examples of types of interventions—comprehensive MAT, medical maintenance, psychosocial interventions, and more—and program characteristics that have been demonstrated to improve retention and outcomes for patients. The consensus panel recommends that program administrators and treatment providers compare their practices with these evidence-based practices and make necessary changes where appropriate. Moreover, OTPs should measure their outcomes continuously, using appropriate program evaluation tools, to improve treatment quality (see chapter 14). Finally, OTPs may want to partner with the research community to investigate and adopt new interventions for improving outcomes.

In addition, SAMHSA has established and funded the Addiction Technology Transfer Center (ATTC) Network, which is dedicated to improving the skills and knowledge of substance abuse treatment providers and increasing their awareness of research findings. Regional centers in the ATTC Network seek to accomplish this goal by identifying and advancing opportunities to improve addiction treatment through the dissemination of new information in response to emerging needs and developments in the treatment field. (For more information, visit the ATTC Web site at www.nattc.org.)

Expanding the Treatment System

Although the number of patients enrolled in OTPs for addiction treatment has almost doubled since 1993, an estimated 898,000 people chronically or occasionally use heroin in the United States (Office of National Drug Control Policy 2003). Only about 20 percent of people who use heroin are being treated. For people who abuse opioid medications normally obtained by prescription, the percentage in treatment is even lower.

Lack of funding for services remains a significant barrier to treatment. In many States, Medicaid does not reimburse MAT services; accordingly, patients, many of whom have limited financial resources, are compelled to finance their treatment.

Making Treatment Available to Criminal Justice Populations

Criminal justice populations are in critical need of opioid addiction treatment, yet most do not have access to MAT (National Center on Addiction and Substance Abuse 1998; National Drug Court Institute 2002; U.S. Department of Justice 1999). Resistance to MAT by many in the criminal justice system may be rooted in the traditional view that medical maintenance treatment is substitution of one drug for another (National Center on Addiction and Substance Abuse 1998). The Rikers Island jail facility in New York City has been providing inmates access to methadone treatment since 1987 (National Drug Court Institute 2002). Rhode Island jail facilities offer a 30-day dose-tapering program. The consensus panel understands that few other correctional institutions have provided MAT services.

Promoting Comprehensive Treatment

In its 1999 publication, Principles of Drug Addiction Treatment: A Research-Based Guide, NIDA stressed the importance of comprehensive treatment services by devoting 3 of the 13 principles of effective drug addiction treatment to comprehensive care (see Exhibit 1-1) (National Institute on Drug Abuse 1999).

Exhibit 1-1. NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment

• Effective treatment attends to multiple needs of the individual, not just his or her drug use.
• Counseling (individual and/or group) and other behavioral therapies are critical components of effective treatment for addiction.
• Medications are an important element of treatment for many patients, especially when combined with counseling and other behavioral therapies.

The consensus panel believes that it is critical to emphasize the central importance of comprehensive care as more physicians begin to use buprenorphine to treat chronic opioid addiction in their private offices. Ideally, a full continuum of care should integrate the services of primary care physicians who dispense opioid treatment medications in private offices and other medication units with the services provided by counselors, case managers, and other essential staff in OTPs.

Combating Stigma

For almost a century, the predominant view of opioid addiction has been that it is a self-induced or self-inflicted condition resulting from a character disorder or moral failing and that this condition is best handled as a criminal matter (see chapter 2). Use of methadone and other therapeutic medications has been viewed traditionally as substitute therapy—merely replacing one addiction with another and the treatment of choice for those too weak to overcome temptation. The stigma associated with MAT has been unique in its permeation of community institutions, affecting the attitudes of medical and health care professionals; social services agencies and workers; paraprofessionals; employers, families, and friends of persons who are opioid addicted; and other people who formerly abused substances, as well as influencing criminal justice policies, creating political opposition, and limiting funding and space for OTPs.

Although diversion control is an important part of MAT, public policy sometimes has seemed to place greater emphasis on protecting society from methadone than on the addiction, violence, and infectious diseases that these medications help alleviate (Institute of Medicine 1995; Joseph et al. 2000; Nadelmann and McNeeley 1996). The cost-effectiveness of MAT often has been overlooked (see chapter 2).

Stigma affects patients in various ways. It discourages them from entering treatment and prompts them to leave treatment early. It creates a barrier for those trying to access other parts of the health care system. A striking example is the failure of many medical practitioners to medicate pain adequately in this group. In addition, the refusal of some organ transplant programs to provide liver transplants to patients maintained on methadone may be a result of stigma, as well as a lack of convincing data on outcomes for methadone patients who receive transplants.

Stigma affects programs too. It prevents new programs from opening when community opposition develops. It can affect a program's internal operations. Staff members who work in OTPs sometimes absorb society's antipathy toward patients in MAT and may deliver program services with a punitive or countertherapeutic demeanor. OTPs must guard against these attitudes through supervision, education, and leadership efforts (see chapter 14).

Several factors have made the destructive force of stigma particularly intractable, including the isolation of MAT from mainstream medicine, negative media reports about treatment, and the public impressions made by poorly run programs. Fortunately, positive changes are occurring in each area.

Positive stories about MAT in the media are sometimes overshadowed by highly charged negative accounts, for example, stories about patients loitering outside OTPs or diversion of take-home doses. SAMHSA, recognizing that “[s]ignificant reduction in stigma and changes in attitudes will require a concerted effort based on systematic research” (CSAT 2000b , p. 4), has undertaken a national educational campaign, titled Partners for Recovery. Many OTP managers and staff members have isolated themselves from their communities, which contributes to negative stereotypes and media stories. Managers and staff members should develop effective skills for working with the media. The consensus panel believes that the patient advocacy movement also can advance a national educational campaign about MAT.

Strong efforts are needed to eliminate stigma within OTPs as well. Staff members should treat patients with respect and pay attention to the terms they use. The term “substitution treatment” should be avoided because it incorrectly implies that long-acting opioid medications act like heroin and other short-acting opioids. Terms such as “dirty” and “clean” in reference to drug-test specimens should be replaced by more clinically useful terms such as “positive” and “negative,” respectively. The use of criminal justice terms such as “probationary treatment” should be replaced with clinically appropriate language (see chapter 14).

Finally, programs should become better neighbors. Idle, perhaps intoxicated, patients who remain near an OTP can become, by default, the program's public representatives and easy targets for complaints from the community. Frequently, patient loitering is a result of insufficient program management. Patient conduct in and around OTPs should be considered both a treatment and a community relations concern.

The Future of MAT

This is an exciting and challenging time for the MAT field, as positive changes accelerate and reinforce one another. The consensus panel hopes that this publication will advance high-quality care in OTPs by providing up-to-date information on science-based, best-treatment practices and by highlighting sound ethical principles of treatment. Equipped with this TIP, the accreditation standards, and a developing alliance with the general medical community, OTPs should be able to improve and expand effective opioid addiction treatment throughout the country.

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