Chapter 4 Preview

A substance use disorder is a medical illness characterized by clinically significant impairments in health, social function, and voluntary control over substance use.² Substance use disorders range in severity, duration, and complexity from mild to severe. In 2015, 20.8 million people aged 12 or older met criteria for a substance use disorder. While historically the great majority of treatment has occurred in specialty substance use disorder treatment programs with little involvement by primary or general health care, a shift is occurring toward the delivery of treatment services in general health care practice. For those with mild to moderate substance use disorders, treatment through the general health care system may be sufficient, while those with severe substance use disorders (addiction) may require specialty treatment.

The good news is that a spectrum of effective strategies and services are available to identify, treat, and manage substance use problems and substance use disorders. Research shows that the most effective way to help someone with a substance use problem who may be at risk for developing a substance use disorder is to intervene early, before the condition can progress. With this recognition, screening for substance misuse is increasingly being provided in general health care settings, so that emerging problems can be detected and early intervention provided if necessary. The addition of services to address substance use problems and disorders in mainstream health care has extended the continuum of care, and includes a range of effective, evidence-based medications, behavioral therapies, and supportive services. However, a number of barriers have limited the widespread adoption of these services, including lack of resources, insufficient training, and workforce shortages.⁵ This is particularly true for the treatment of those with co-occurring substance use and physical or mental disorders.^6,7

This chapter provides an overview of the scientific evidence supporting the effectiveness of treatment interventions, therapies, services, and medications available to identify, treat, and manage substance use problems and disorders.

Continuum of Treatment Services

Substance use disorders typically emerge during adolescence and often (but not always) progress in severity and complexity with continued substance misuse.^9,10 Currently, substance use disorders are classified diagnostically into three severity categories: mild, moderate, and severe.²

Substance use disorder treatment is designed to help individuals stop or reduce harmful substance misuse, improve their health and social function, and manage their risk for relapse. In this regard, substance use disorder treatment is effective and has a positive economic impact. Research shows that treatment also improves individuals' productivity,¹¹ health,^11,12 and overall quality of life.^13-15 In addition, studies show that every dollar spent on substance use disorder treatment saves $4 in health care costs and $7 in criminal justice costs.¹¹

Mild substance use disorders can be identified quickly and reliably in many medical and social settings. These common but less severe disorders often respond to brief motivational interventions and/or supportive monitoring, referred to as guided self-change.¹⁶ In contrast, severe, complex, and chronic substance use disorders often require specialty substance use disorder treatment and continued post-treatment support to achieve full remission and recovery. To address the spectrum of substance use problems and disorders, a continuum of care provides individuals an array of service options based on need, including prevention, early intervention, treatment, and recovery support (Figure 4.1). Traditionally, the vast majority of treatment for substance use disorders has been provided in specialty substance use disorder treatment programs, and these programs vary substantially in their clinical objectives and in the frequency, intensity, and setting of care delivery.

Figure 4.1

Substance Use Status and Substance Use Care Continuum.

This chapter describes the early intervention and treatment components of the continuum of care, the major behavioral, pharmacological, and service components of care, services available, and emerging treatment technologies:

• Early Intervention, for addressing substance misuse problems or mild disorders and helping to prevent more severe substance use disorders.
• Treatment engagement and harm reduction interventions, for individuals who have a substance use disorder but who may not be ready to enter treatment, help engage individuals in treatment and reduce the risks and harms associated with substance misuse.
• Substance use disorder treatment, an individualized set of evidence-based clinical services designed to improve health and function, including medications and behavioral therapies.
• Emerging treatment technologies are increasingly being used to support the assessment, treatment, and maintenance of continuing contact with individuals with substance use disorders.

Early Intervention: Identifying and Engaging Individuals At Risk for Substance Misuse and Substance Use Disorders

Early intervention services can be provided in a variety of settings (e.g., school clinics, primary care offices, mental health clinics) to people who have problematic use or mild substance use disorders.¹⁷ These services are usually provided when an individual presents for another medical condition or social service need and is not seeking treatment for a substance use disorder. The goals of early intervention are to reduce the harms associated with substance misuse, to reduce risk behaviors before they lead to injury,¹⁸ to improve health and social function, and to prevent progression to a disorder and subsequent need for specialty substances use disorder services.^17,18 Early intervention consists of providing information about substance use risks, normal or safe levels of use, and strategies to quit or cut down on use and use-related risk behaviors, and facilitating patient initiation and engagement in treatment when needed. Early intervention services may be considered the bridge between prevention and treatment services. For individuals with more serious substance misuse, intervention in these settings can serve as a mechanism to engage them into treatment.¹⁷

Components of Early Intervention

One structured approach to delivering early intervention to people showing signs of substance misuse and/or early signs of a substance use disorder is through screening and brief intervention (SBI).²²

Research has shown that several methods of SBI are effective in decreasing “at-risk” substance use and that they work for a variety of populations and in a variety of health care settings.^22,23 As mentioned earlier, this research has demonstrated positive effects for reducing alcohol use;^24,25 the research with SBI among those with other substance use disorders has shown mixed results.^26-29

In addition, research shows that SBI can be cost-effective. For example, a randomized study compared SBI to screening alone for alcohol and drug use disorders among patients covered by Medicaid in eight emergency medicine clinics in the State of Washington. A year later, investigators compared total Medicaid expenditures between the two groups and found that the costs per member, per month for the SBI group were $185 to $192 lower than the costs for the screening-only group. This added up to a savings of more than $2,200 per patient in one year.³⁰

FOR MORE ON THIS TOPIC

See Chapter 6 - Health Care Systems and Substance Use Disorders.

SBI: Screening

Ideally, substance misuse screening should occur for all individuals who present in health care settings, including primary, urgent, psychiatric, and emergency care. Professional organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, the American Academy of Family Physicians, and the American Academy of Pediatrics recommend universal and ongoing screening for substance use and mental health issues for adults and adolescents.^31-36 Such screening practices can help identify the severity of the individual's substance use and whether substance use disorder treatment may be necessary.

Within these contexts, substance misuse can be reliably identified through dialogue, observation, medical tests, and screening instruments.³⁷ Several validated screening instruments have been developed to help non-specialty providers identify individuals who may have, or be at risk for, a substance use disorder.

Table 4.1 provides examples of available substance use screening tools, how they are used, and for which age groups. In addition to these tools, single-item screens for presence of drug use (“How many times in the past year have you used an illegal drug or used a prescription medication for nonmedical reasons?”) and for alcohol use (“How many times in the past year have you had X or more drinks in a day?”, where X is 5 for men and 4 for women) have been validated and shown in primary care to accurately identify individuals at risk for or experiencing a substance use disorder.^38-42

Table 4.1

Evidence-Based Screening Tools for Substance Use.

SBI: Brief Interventions

Brief interventions (or brief advice) range from informal counseling to structured therapies. They often include feedback to the individual about their level of use relative to safe limits, as well as advice to aid the individual in decision-making.¹⁷

Motivational interviewing (MI) is a client-centered counseling style that addresses a person's ambivalence to change. A counselor uses a conversational approach to help their client discover their interest in changing their substance using behavior. The counselor asks the client to express their desire for change and any ambivalence they might have and then begins to work with the client on a plan to change their behavior and to make a commitment to the change process. The main purpose of MI is to examine and resolve ambivalence, and the counselor is intentionally directive in pursuing this goal.⁴⁴ It is effective in reducing the substance misuse of patients who come to medical settings for other health-related conditions.⁴⁵ In these settings, individuals who receive MI are more likely to adhere to a treatment plan and, subsequently, to have better outcomes.^24,46

SAMHSA SBIRT Education

SAMHSA offers free SBIRT Continuing Medical Education and Continuing Education courses for providers.

Adding Referral to Treatment When Necessary

When an individual's substance use problem meets criteria for a substance use disorder, and/or when brief interventions do not produce change, it may be necessary to motivate the patient to engage in specialized treatment. This is called Screening, Brief Intervention, and Referral to Treatment (SBIRT). In such cases, the care provider makes a referral for a clinical assessment followed by a clinical treatment plan developed with the individual that is tailored to meet the person's needs.⁴⁷ Effective referral processes should incorporate strategies to motivate patients to accept the referral. Although the screening and brief intervention components of SBIRT are the same as SBI, referral to treatment helps the individual access, select, and navigate barriers to substance use disorder treatment.

The literature on the effectiveness of drug-focused brief intervention in primary care and emergency departments is less clear, with some studies finding no improvements among those receiving brief interventions.^48,49 However, at least one study found significant reductions in subsequent drug use.⁵⁰ Even if brief interventions are not found to be sufficient to address patients' drug use disorders, general health care settings still have an important role to play in addressing drug use disorders, by providing medication-assisted treatment (MAT), providing more robust monitoring and care coordination, and actively promoting engagement in specialty substance use disorder treatment.

Trials evaluating different types of screening and brief interventions for drug use in a range of settings and on a range of patient characteristics are lacking. Recently, efforts have been made to adapt SBIRT for adolescents and for all groups with substance use disorders.^51,52 The results of preliminary studies are promising,^20,53 but gaps in knowledge about SBIRT for adolescents still need to be filled.⁵⁴

Treatment Engagement: Reaching and Reducing Harm Among Those Who Need Treatment

Principles of Effective Treatment and Treatment Planning

Principles and Goals of Treatment

Treatment can occur in a variety of settings but most treatment for substance use disorders has traditionally been provided in specialty substance use disorder treatment programs. For this reason, the majority of research has been performed within these specialty settings.⁹¹ The following sections describe what is known from this research about the processes, stages of, and outcomes from traditional substance use disorder treatment programs.

The National Institute on Drug Abuse (NIDA) has detailed the evidence-based principles of effective treatment for adults and adolescents with substance use disorders that apply regardless of the particular setting of care or type of substance use disorder treatment program (Table 4.2).^85,92

Table 4.2

Principles of Effective Treatment for Substance Use Disorders.

The goals of substance use disorder treatment are similar to those of treatments for other serious, often chronic, illnesses: reduce the major symptoms of the illness, improve health and social function, and teach and motivate patients to monitor their condition and manage threats of relapse. Substance use disorder treatment can be provided in inpatient or outpatient settings, depending on the needs of the patient, and typically incorporates a combination of behavioral therapies, medications, and RSS. However, unlike treatments for most other medical illnesses, substance use disorder treatment has traditionally been provided in programs (both residential and outpatient) outside of the mainstream health care system. The intensity of the treatment regimens offered can vary substantially across program types. The American Society of Addiction Medicine (ASAM) has categorized these programs into “levels” of care to guide referral based on an individual patient's needs.^93-95

Despite differences in care delivery and differences in reimbursement, substance use disorder treatments have approximately the same rates of positive outcomes as treatment for other chronic illnesses. Relapse rates for substance use disorders (40 to 60 percent) are comparable to those for chronic diseases, such as diabetes (20 to 50 percent), hypertension (50 to 70 percent), and asthma (50 to 70 percent).¹²

KEY CONCEPT

Treatment varies depending on substance(s) used, severity of substance use disorder, comorbidities, and the individual's preferences.

Treatment typically includes medications and counseling as well as other social supports such as linkage to community recovery groups depending on an individual patient's needs and level of existing family and social support.

The general process of treatment planning and delivery for individuals with severe substance use disorders is described below, along with an explanation of the evidence-based therapies, medications, and RSS shown to be effective in treatment.

Treatment Planning

Assessment and Diagnosis

Among the first steps involved in substance use disorder treatment are assessment and diagnosis. The diagnosis of substance use disorders is based primarily on the results of a clinical interview. Several assessment instruments are available to help structure and elicit the information required to diagnose substance use disorders. The diagnosis of a substance use disorder is made by a trained professional based on 11 symptoms defined in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). These symptoms, which are generally related to loss of control over substance use,⁹⁶ are presented in Table 1.5² in Chapter 1. The number of diagnostic symptoms present defines the severity of the disorder, ranging from mild to severe (i.e., fewer than 2 symptoms = no disorder; 2 to 3 symptoms = mild disorder; 4 to 5 symptoms = moderate disorder; 6 or more symptoms = severe disorder).⁹⁷

FOR MORE ON THIS TOPIC

See Chapter 1 - Introduction and Overview.

Conducting a clinical assessment is essential to understanding the nature and severity of the patient's health and social problems that may have led to or resulted from the substance use. This assessment is important in determining the intensity of care that will be recommended and the composition of the treatment plan.⁹¹ Several validated assessment tools can provide information about an individual's substance use disorder. Table 4.3 gives a brief overview of some of the tools that are available.

Table 4.3

Detailed Information on Substance Use Disorder Assessment Tools.

Individualized Treatment Planning

After a formal assessment, the information is discussed with the patient to jointly develop a personalized treatment plan designed to address the patient's needs.^91,101 The treatment plan and goals should be person-centered and include strength-based approaches, or ones that draw upon an individual's strengths, resources, potential, and ability to recover, to keep the patient engaged in care. Individualized treatment plans should consider age, gender identity, race and ethnicity, language, health literacy, religion/spirituality, sexual orientation, culture, trauma history, and co-occurring physical and mental health problems. Such considerations are critical for understanding the individual and for tailoring the treatment to his or her specific needs. This increases the likelihood of successful treatment engagement and retention, and research shows that those who participate more fully in treatment typically have better outcomes.¹⁰² Throughout treatment, individuals should be periodically reassessed to determine response to treatment and to make any needed adjustments to the treatment plan.

Maintaining Treatment Engagement and Retention

Treatment plans should be personalized and include engagement and retention strategies to promote participation, motivation, and adherence to the plan.⁴⁷ Research has found that individuals who received proactive engagement services such as direct outreach and a specific follow-up plan are more likely to remain engaged in services throughout the treatment process.^47,103,104

Treatment providers can improve engagement and retention in programs by building a strong therapeutic alliance with the patient, effectively using evidence-based motivational strategies, acknowledging the patient's individual barriers, making reminder phone calls, and creating a positive environment.¹⁰⁵ Further, providers who can recommend and/or provide a broad range of RSS, such as child care, housing, and transportation, can improve retention in treatment.¹⁰⁶

Engaging, effective treatment also involves culturally competent care. For example, treatment programs that provide gender-specific and gender-responsive care are more likely to enhance women's treatment outcomes.¹⁰⁷ Tailoring treatment to involve family and community is particularly effective for certain groups. For example, American Indians or Alaska Natives may require specific elements in their treatment plan that respond to their unique cultural experiences and to intergenerational and historical trauma and trauma from violent encounters.¹⁰⁸ Language and literacy (including health literacy) may also affect how a person responds to the treatment environment.^109-112 Race and ethnicity, sexual orientation, gender identity, and economic status can play significant roles in treatment initiation, engagement, and completion.^107,113,114

Substance use disorder treatment programs also have an obligation to prepare for disasters within their communities that can affect the availability of services. A disaster can disrupt a program's ability to provide treatment services or an individual's ability to maintain treatment. Individuals in recovery, for example, may relapse due to sudden discontinuation of services or stress when having to cope with effects of a disaster. Individuals receiving MAT could be at risk of serious withdrawal symptoms if medications are stopped abruptly. Others may face challenges without their treatment program's support.¹¹⁵ Therefore, planning for disasters and other large scale emergencies is critical to prevent or reduce the impact of interruptions in treatment services.

Treatment Setting and the Continuum of Care

As indicated above, the treatment of addiction is delivered in predominantly freestanding programs that differ in their setting (hospital, residential, or outpatient); in the frequency of care delivery (daily sessions to monthly visits); in the range of treatment components offered; and in the planned duration of care. In general, as patients progress in treatment and begin to meet the goals of their individualized treatment plan, they transfer from clinical management in residential or intensive outpatient programs to less clinically intensive outpatient programs that promote patient self-management.

A typical progression for someone who has a severe substance use disorder might start with 3 to 7 days in a medically managed withdrawal program, followed by a 1- to 3-month period of intensive rehabilitative care in a residential treatment program, followed by continuing care, first in an intensive outpatient program (2 to 5 days per week for a few months) and later in a traditional outpatient program that meets 1 to 2 times per month. For many patients whose current living situations are not conducive to recovery, outpatient services should be provided in conjunction with recovery-supportive housing.

FOR MORE ON THIS TOPIC

See Chapter 5 - Recovery: The Many Paths to Wellness.

In general, patients with serious substance use disorders are recommended to stay engaged for at least 1 year in the treatment process, which may involve participation in three to four different programs or services at reduced levels of intensity, all of which are ideally designed to help the patient prepare for continued self-management after treatment ends.^56,116 This expected trajectory of care explains why efforts to maintain patient motivation and engagement are important. Brief summaries of the major levels of the treatment continuum are discussed below.

Medically monitored and managed inpatient care is an intensive service delivered in an acute, inpatient hospital setting.¹⁸ These programs are typically necessary for individuals who require withdrawal management, primary medical and nursing care, and for those with co-occurring mental and physical health conditions.¹⁸ Treatment is usually provided by an interdisciplinary team of health care professionals, available 24 hours a day, who can address serious mental and physical health needs.^18,91

FOR MORE ON THIS TOPIC

See the section on “Acute Stabilization and Withdrawal Management” earlier in this chapter.

Residential services offer organized services, also in a 24-hour setting but outside of a hospital. These programs typically provide support, structure, and an array of evidence-based clinical services.¹⁸ Such programs are appropriate for physically and emotionally stabilized individuals who may not have a living situation that supports recovery, may have a history of relapse, or have co-occurring physical and/or mental illnesses.

Partial hospitalization and intensive outpatient services range from counseling and education to clinically intensive programming.¹⁸ Partial hospitalization programs are used as a step-down treatment option after completing residential treatment and are usually available 6 to 8 hours a day during the work week.¹⁸ These services are considered to be approximately as intensive but less restrictive than residential programs⁹¹ and are appropriate for patients living in an environment that supports recovery but who need structure to avoid relapse.

Outpatient services provide both group and individual behavioral interventions and medications when appropriate.⁹¹ These components of care can be offered during the day, before or after work or school, or in the evenings and weekends. Typically, outpatient programs are appropriate as the initial level of care for individuals with a mild to moderate substance use disorder or as continuing care after completing more intensive treatment.¹⁸ Outpatient programs are also suitable for individuals with co-occurring mental health conditions.

Evidence-based Treatment: Components of Care

Regardless of the substance for which the individual seeks treatment or the setting or level of care, all substance use disorder treatment programs are expected to offer an individualized set of evidence-based clinical components. These components are clinical practices that research has shown to be effective in reducing substance use and improving health and functioning. These include behavioral therapies, medications, and RSS. Treatment programs that offer more of these evidence-based components have the greatest likelihood of producing better outcomes.

Medications and Medication-Assisted Treatment

Five medications, approved by the FDA, have been developed to treat alcohol and opioid use disorders. Currently, no approved medications are available to treat marijuana, amphetamine, or cocaine use disorders.¹¹⁷ Table 4.4 lists these medications and they are discussed individually in the text that follows.

Table 4.4

Pharmacotherapies Used to Treat Alcohol and Opioid Use Disorders.

Like all other FDA-approved medications, those listed in Table 4.4 demonstrate “well-supported” experimental evidence of safety and effectiveness¹²⁰ for improving outcomes for individuals with alcohol and opioid use disorders.¹¹⁷ At the same time, all of these medications have side effects; two (methadone and buprenorphine) have the potential to be misused, and methadone (and to a lesser extent buprenorphine) has the potential for overdose. For these reasons, only appropriately trained health care professionals should decide whether medication is needed as part of treatment, how the medication is provided in the context of other clinical services, and under what conditions the medication should be withdrawn or terminated.

The combination of behavioral interventions and medications to treat substance use disorders is commonly referred to as MAT.¹²¹ MAT is a highly effective treatment option for individuals with alcohol and opioid use disorders. Studies have repeatedly demonstrated the efficacy of MAT at reducing illicit drug use and overdose deaths,^122,123 improving retention in treatment,¹²⁴ and reducing HIV transmission.¹²²

Some medications used to treat opioid use disorders can be used to manage withdrawal and as maintenance treatment to reduce craving, lessen withdrawal symptoms, and maintain recovery.⁵⁶ These medications are used to help a patient function comfortably without illicit opioids or alcohol while balance is gradually restored to the brain circuits that have been altered by prolonged substance use.

FOR MORE ON THIS TOPIC

See Chapter 2 - The Neurobiology of Substance Use, Misuse, and Addiction.

Prescribed in this fashion, medications for substance use disorders are in some ways like insulin for patients with diabetes. Insulin reduces symptoms by normalizing glucose metabolism, but it is part of a broader disease control strategy that also employs diet change, education on healthy living, and self-monitoring. Whether treating diabetes or a substance use disorder, medications are best employed as part of a broader treatment plan involving behavioral health therapies and RSS, as well as regular monitoring.

State agencies that oversee substance use disorder treatment programs use a variety of strategies to promote implementation of MAT, including education and training, financial incentives (e.g., linking funding to the provision of MAT), policy mandates, and support for infrastructure development.⁵ Nevertheless, multiple factors create barriers to widespread use of MAT. These include provider, public, and client attitudes and beliefs about MAT; lack of an appropriate infrastructure for providing medications; need for staff training and development; and legislation, policies, and regulations that limit MAT implementation.⁵

Medication-Assisted Treatment for Opioid Use Disorders

MAT for patients with a chronic opioid use disorder must be delivered for an adequate duration in order to be effective. Patients who receive MAT for fewer than 90 days have not shown improved outcomes.¹²⁵ One study suggested that individuals who receive MAT for fewer than 3 years are more likely to relapse than those who are in treatment for 3 or more years.¹²⁶ Three medications are commonly used to treat opioid use disorders: methadone, buprenorphine, and naltrexone.

Methadone is a synthetic opioid agonist that has been used to treat the symptoms of withdrawal from heroin and other opioids.¹²⁷ More than 40 years of research support the use of methadone as an effective treatment for opioid use disorder.^121,128,129 It is also used in the treatment of patients with chronic, severe pain¹³⁰ as a therapeutic alternative to morphine sulfate and other opioid analgesics.¹³¹ Any licensed physician can prescribe methadone for the treatment of pain, but methadone may only be dispensed for treatment of an opioid use disorder within licensed methadone treatment programs.

KEY TERMS

Agonist. A chemical substance that binds to and activates certain receptors on cells, causing a biological response. Fentanyl and methadone are examples of opioid receptor agonists.

Long-term methadone maintenance treatment for opioid use disorders has been shown to be more effective than short-term withdrawal management,¹³² and it has demonstrated improved outcomes for individuals (including pregnant women and their infants) with opioid use disorders.¹³³ Studies have also indicated that methadone reduces deaths, HIV risk behaviors, and criminal behavior associated with opioid drug seeking.^134,135

The use of methadone to treat opioid use disorders has much in common with treatments for other substance use disorders and other chronic illnesses. However, it has one significant structural and cultural difference. Under regulations dating back to the early 1970s, the federal government created special methadone programs for adults with opioid use disorders. Originally referred to as “methadone treatment programs,” these treatment facilities were created to provide special management of the medical and legal issues associated with the use of this potent, long-acting opioid.

The use of opioid agonist medications to treat opioid use disorders has always had its critics. Many people, including some policymakers, authorities in the criminal justice system, and treatment providers, have viewed maintenance treatments as “substituting one substance for another”⁸⁵ and have adhered instead to an abstinence-only philosophy that avoids the use of medications, especially those that activate opioid receptors. Such views are not scientifically supported; the research clearly demonstrates that MAT leads to better treatment outcomes compared to behavioral treatments alone. Moreover, withholding medications greatly increases the risk of relapse to illicit opioid use and overdose death. Decades of research have shown that the benefits of MAT greatly outweigh the risks associated with diversion.

KEY TERMS

Drug diversion. A medical and legal concept involving the transfer of any legally prescribed controlled substance from the person for whom it was prescribed to another person for any illicit use.

Today, methadone treatment programs, now called Opioid Treatment Programs (OTPs), must be certified by SAMHSA and registered by the U.S. Drug Enforcement Administration (DEA). OTPs are predominantly outpatient programs (approximately 95 percent) that provide pharmacotherapy in combination with behavioral therapies and other RSS.¹³⁶ OTPs incorporate principles of harm reduction and benefit both program participants and the community¹³⁷ by reducing opioid use, mortality, crime associated with opioid use disorders, and infectious disease transmission. Buprenorphine and naltrexone may also be provided in OTPs.⁶¹

Individuals receiving medication for opioid use disorders in an OTP must initially take their doses daily under observation.^138,139 After a period of orientation, patients are typically started at a dose of 20 to 30 mg and gradually increased to 80 mg or more per day, until craving and opioid misuse are significantly reduced. During this period, all dosing occurs at the OTP, but following stabilization and initially positive results, the stabilized patient may be given a “take-home” supply of his or her dose to self-administer per the federal opioid treatment standard regulations 42 CFR 8.12(i).

Buprenorphine is available as a sublingual tablet and a sublingual or buccal film. In addition, in May 2016, an implantable formulation of buprenorphine was approved by the FDA. For individuals who are already on a stable low to moderate dose of buprenorphine, the implant delivers a constant low dose of buprenorphine for 6 months. Buprenorphine is associated with improved outcomes compared to placebo for individuals (including pregnant women and their infants) with opioid use disorders,¹⁴⁰ and it is effective in reducing illegal opioid use.¹²⁹

Buprenorphine is a partial opioid agonist, meaning that it binds to and activates opioid receptors but with less intensity than full agonists. As a result, there is an upper limit to how much euphoria, pain relief, or respiratory depression buprenorphine can produce.^56,141 However, buprenorphine still may result in overdose if used with tranquilizers and/or alcohol, and some diversion has been reported, although studies suggest most diverted buprenorphine is used therapeutically (e.g., to control cravings), not to get high.^142-144

Clinical experience and research protocols indicate that buprenorphine initiation and stabilization during the induction period is an important part of successful treatment for individuals with opioid use disorder.¹⁴⁵ Buprenorphine can be prescribed alone or as a combination medication that includes naloxone, an opioid antagonist medication.¹⁴⁵ If this combined medication is taken as prescribed, the naloxone has no appreciable effects. However, if the combined medication is injected, the naloxone component can precipitate an opioid withdrawal syndrome, and in this way serves as a deterrent to misuse by injection.¹⁴⁵

Buprenorphine may be prescribed by physicians who have met the statutory requirements for a waiver in accordance with the Controlled Substances Act (21 U.S.C. 823(g)(2)(D)(iii)).¹⁴⁶ However, physicians using the waiver are limited in the number of patients they can treat with this medication. This patient limit does not apply to OTPs that dispense buprenorphine on site because the OTP operating in this capacity is doing so under 21 U.S.C. 823(g)(1) and 42 CFR Part 8, and not under 21 U.S.C. 823(g)(2)(B).

When they first receive their waiver, physicians can provide buprenorphine treatment for only up to 30 individuals. After the first year they can request to treat up to 100.¹⁴⁷ However, lack of physician availability to prescribe buprenorphine has been a significant limitation on access to this effective medication. Although approximately 435,000 primary care physicians practice medicine in the United States,¹⁴⁸ only slightly more than 30,000 have a buprenorphine waiver,¹⁴⁹ and only about half of those are actually treating opioid use disorders.¹⁵⁰ To address this limitation and narrow the treatment gap, a final rule was published on July 8, 2016, expanding access to MAT by allowing eligible practitioners to request approval to treat up to 275 patients.¹⁴⁷

Additionally, on July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) was signed into law. CARA temporarily expands eligibility to prescribe buprenorphine-based drugs for MAT for substance use disorders to qualifying nurse practitioners and physician assistants through October 1, 2021.

FOR MORE ON THIS TOPIC

See the section on “Comprehensive Addiction and Recovery Act (CARA)” in Chapter 6 - Health Care Systems and Substance Use Disorders.

Naltrexone is an opioid antagonist that binds to opioid receptors and blocks their activation; it produces no opioid-like effects and is not abusable. It prevents other opioids from binding to opioid receptors so that they have little to no effect. It also interrupts the effects of any opioids in a person's system, precipitating an opioid withdrawal syndrome in opioid-dependent patients, so it can be administered only after a complete detoxification from opioids. There is also no withdrawal from naltrexone when the patient stops taking it. Naltrexone may be appropriate for people who have been successfully treated with buprenorphine or methadone who wish to discontinue use but still be protected from relapse; people who prefer not to take an opioid agonist; people who have completed detoxifications and/or rehabilitation or are being released from incarceration and expect to return to an environment where drugs may be used and wish to avoid relapse; and adolescents or young adults with opioid dependence.¹⁵¹

Because naltrexone is not a controlled substance, it can be prescribed or administered by any physician, nurse practitioner, or physician assistant with prescribing authority. Naltrexone comes in two formulations: oral and extended-release injectable. Oral naltrexone can be effective for those individuals who are highly motivated and/or supported with observed daily dosing. Extended-release injectable naltrexone, which is administered on a monthly basis, addresses the poor compliance associated with oral naltrexone since it provides extended protection from relapse and reduces cravings for 30 days.^152,153

Medication-Assisted Treatment for Alcohol Use Disorders

A number of factors should be weighed in determining the need for medication when treating an individual for an alcohol use disorder, such as the patient's motivation for treatment, potential for relapse, and severity of co-existing conditions.¹²⁰ Three FDA-approved medications are currently available to treat alcohol use disorder: disulfiram, naltrexone, and acamprosate.¹¹⁷ None of these medications carries a risk of misuse or addiction, and thus none is a DEA-scheduled substance. Each has a distinct effectiveness and side effect profile. Prescribing health care professionals should be familiar with these side effects and take them into consideration before prescribing.¹⁵⁴ Providers can obtain additional information from materials produced by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and SAMHSA.^155,156

Research studies on the efficacy of medications to treat alcohol use disorders have demonstrated that most patients show benefit, although individual response can be difficult to predict.^154,157 MAT interventions for alcohol use disorders can be provided in both non-specialty and specialty care settings and are most beneficial when combined with behavioral interventions and brief support.¹⁵⁴

Disulfiram is a medication that inhibits normal breakdown of acetaldehyde which is produced by the metabolism of alcohol, thus rapidly increasing acetaldehyde in the blood which produces an aversive response. Thus, once disulfiram is taken by mouth, any alcohol consumed results in rapid buildup of acetaldehyde and a negative reaction or sickness results. The intensity of this reaction is dependent on the dose of disulfiram and the amount of alcohol consumed.¹⁵⁸ Effects from a disulfiram-alcohol reaction include warmth and flushing of the skin, increased heart rate, palpitations, a drop in blood pressure, nausea and/or vomiting, sweating, dizziness, and headache.¹⁵⁹ In this way, disulfiram essentially punishes alcohol consumption and indirectly rewards abstinence.¹¹⁷

Disulfiram was the first medication approved by the FDA to treat alcohol use disorder and its efficacy has been widely studied.¹⁶⁰ Most studies have demonstrated that disulfiram, when given under supervision, is more effective than placebo in treating alcohol use disorders.¹⁵⁴ A major limitation of disulfiram is adherence, which is typically poor, thereby reducing the medication's effectiveness. Disulfiram is most effective when its use is supervised or observed, which has been found to increase compliance.^154,159 Negotiating with the patient to have a spouse or significant other provide supervision offers both the incentive to take the medication and the documentation that the medication is being taken.¹⁶¹ The best candidates for disulfiram are patients with motivation for treatment and a desire to be abstinent. Thus, an individual who wants to reduce, but not stop, drinking is not a candidate for disulfiram. Disulfiram should also be avoided in individuals with advanced liver disease.¹⁶²

Naltrexone is the opioid antagonist described above that is used to treat opioid use disorder. Because it blocks some opioid receptors, naltrexone counteracts some of the pleasurable aspects of drinking.^154,159 Unlike disulfiram, naltrexone does not interact with alcohol to produce a severe reaction.¹⁶³ As noted before, naltrexone comes in two formulations: oral and extended-release injectable.

Many studies have examined the effectiveness of naltrexone in treating alcohol use disorders.¹⁵⁴ Several research reviews have found that it reduces the risk of heavy drinking in patients who are abstinent for at least several days at the time treatment begins.^154,160 However, as with disulfiram, medication compliance can be a problem with the oral formulation. Adherence to taking the medication increases under conditions where it is administered and observed by a trusted family member or when the extended-release injectable, which requires only a single monthly injection, is used.¹⁶⁴ Naltrexone should not be prescribed to patients with acute hepatitis, renal failure, or liver failure.¹⁶²

Acamprosate is a medication that normalizes the alcohol-related neurochemical changes in the brain glutamate systems and thereby reduces the symptoms of craving that can prompt a relapse to pathological drinking.¹¹⁷ Acamprosate has been found to be an effective medication when used concurrently with behavioral interventions and, as with other medications for alcohol use disorders, works best in motivated patients.^117,165 Reviews show that acamprosate is effective in reducing relapse¹⁶⁶ and effective when used to maintain abstinence from alcohol.¹⁶⁷

Emerging Treatment Technologies

Technological advancements are changing not only the face of health care generally, but also the treatment of substance use disorders. In this regard, approximately 20 percent of substance use disorder treatment programs have adopted electronic health record (EHR) systems. With the growing adoption of EHRs, individuals and their providers can more easily access and share treatment records to improve coordination of care.²¹⁶ In turn, information sharing through EHRs can lead to improved quality and efficiency of service delivery, reduced treatment gaps, and increased cost savings to health systems.

The use of telehealth to deliver health care, provide health information or education, and monitor the effects of care, has also rapidly increased.²¹⁷ Telehealth can be facilitated through a variety of media, including smartphones, the Internet, videoconferencing, wireless communication, and streaming media. It offers alternative, cost-effective care options for individuals living in rural or remote areas or when physically travelling to a health care facility poses significant challenges.

Technology-based interventions offer many potential advantages. They can increase access to care in underserved areas and settings; free up time so that service providers can care for more clients; provide alternative care options for individuals hesitant to seek in-person treatment; increase the chances that interventions will be delivered as they were designed and intended to be delivered; and decrease costs.^218-222 Further, studies show that most individuals already have access to the necessary tools to engage in technology-based care; about 92 percent of United States adults own a cell phone²²³ and 85 percent use the Internet.²²⁴

Research on the effectiveness of technology-assisted care within substance use disorder treatment focuses on three main applications: (1) technology as an add-on to enhance standard care; (2) technology as a substitute for a portion of standard care; and (3) technology as a replacement for standard care.²²¹ The current evidence base of technology-based interventions for substance use disorder treatment is limited, though it is growing.^221,225-227 For this reason, these technologies can only be considered “promising” at this time. Table 4.5 shows the state of evidence supporting innovative technology-assisted interventions, several of which are discussed in the Electronic Treatment Interventions and Electronic Clinical and Recovery Support Tools sections.

Table 4.5

Examples of Technology-Assisted Interventions.

Considerations for Specific Populations

Recommendations for Research

Although the field of treatment for substance use disorders has made substantial progress, additional types of research are needed. Research involving early interventions and various components of treatment must move from rigorously controlled trials to natural delivery settings and a broader mix of patient types. Because rigorously controlled trials must focus on specific diagnoses and carefully characterized patient types, it is often the case that the samples used in these trials are not representative of the real-world populations who need treatment. For example, many opioid medication trials involve “opioid-only” populations, whereas in practice most patients with opioid use disorders also have alcohol, marijuana, and/or cocaine use disorders. Rigorously controlled trials are necessary to establish efficacy, but interventions that seem to be effective in these studies too often cannot be implemented in real-world settings because of a lack of workforce training, inadequate insurance coverage, and an inability to adequately engage the intended patient population.

As has been documented in several chapters within this Report, the great majority of patients with substance use disorders do not receive any form of treatment. Nonetheless, many of these individuals do access primary or general medical care in community clinics or school settings and research is needed to determine the availability and efficacy of treatment in these settings and to identify ways in which access to treatment in these settings could be improved. The current failure to acknowledge and address substance use disorders in these settings has reduced the quality and increased the costs of health care. Moreover, access and referral to specialty substance use disorder care from primary care settings is neither easy nor quick. Better integration between primary care and specialty care and additional treatment options within primary care are needed. Primary care physicians need to be better prepared to identify, assist, and refer patients, when appropriate. If treatment is delivered in primary care, it should be practical for delivery within these settings and attractive, engaging, accessible and affordable for affected patients.

Buprenorphine or naloxone treatment for opioid misuse should also be available in emergency departments.²⁹⁷ Here, the goals of treatment would be the reduction of substance use combined with better engagement in and adherence to treatment for any associated medical illness. Therefore, treatment research outside of traditional substance use disorder treatment programs is needed.

As of June 2016, four states, plus the District of Columbia, have legalized recreational marijuana, and many more have permitted medical marijuana use. The impact of the changes on levels of marijuana and other drug and alcohol use, simultaneous use, and related problems such as motor vehicle crashes and deaths, overdoses, hospitalizations, and poor school and work performance, must be evaluated closely. Accurate and practical marijuana screening and early intervention procedures for use in general and primary care settings are needed. Not only must it be determined which assessment tools are appropriate for the various populations that use marijuana, but also which treatments are generalizable from research to practice, especially in primary care and general mental health care settings.

Current research suggests that it is useful to educate and train first responders, peers, and family members of those who use opioids to use naloxone to prevent and reverse potential overdose-related deaths. However, more research is needed to identify strategies to encourage the subsequent engagement of those who have recovered from overdose into appropriate treatment. In this work, it will be important to consider contextual factors such as age, gender identity, race and ethnicity, sexual orientation, economic status, community resources, faith beliefs, co-occurring mental or physical illness, and many other personal issues that can work against the appropriateness and ultimately the usefulness of a treatment strategy.

Opioid agonist therapies are effective in stabilizing the lives of individuals with severe opioid use disorders. However, many important clinical and social questions remain about whether, when, and how to discontinue medications and related services. This is an important question for many other areas of medicine where maintenance medications are continued without significant change and often without attention to other areas of clinical progress.

At the same time, it is clear from many studies over the decades that detoxification following an arbitrary maintenance time period (e.g., 90 days, 180 days), or performed without continuing supports, is rarely effective in disengaging patients from opioid use disorders and may lead to relapse and overdose. Thus, more research is needed to explore if, when, and how patients can be transitioned from MAT to non-medication status within the context of “personalized medicine,” to provide both patients and clinical staff appropriate therapeutic guidance.

Regarding personalized medicine, research is needed on how to implement multidisciplinary, collaborative, and patient-centered care for persons with opioid use disorders and chronic pain, in a manner effectively treating both diseases together with any psychiatric comorbidities that may undermine recovery. Precision medicine research is also needed on how to individually tailor such interventions to optimize care management for patient groups in which there is overlap between pain-related psychological distress and stress-related opioid misuse.²⁹⁸

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