SAMHSA releases Clinical Use of Extended-Release Injectable Naltrexone in the Treatment of Opioid Use Disorders: A Brief Guide

Brief guide offers guidance on the use of medication-assisted treatment (MAT) with extended-release injectable naltrexone for the treatment of an opioid use disorder. Covers patient assessment, initiating MAT, monitoring progress, and deciding when to end treatment.


The profile of opioid misuse and opioid use disorder in the United States is changing, in that nonmedical use of prescription opioids has become as significant a problem as the use of heroin.1 Federal data for 2013 indicate that approximately 4.5 million people in the United States reported nonmedical use of prescription pain relievers in the past month and 289,000 reported use of heroin in the past month.2 Despite the dimensions of the problem, nearly 80 percent of people with an opioid use disorder do not receive treatment because of limited treatment capacity, financial obstacles, social bias, and other barriers to care.3

Researchers, federal health agencies, and pharmaceutical manufacturers have focused on developing medications that can be used to expand access to treatment of an opioid use disorder in medical office settings, rather than limiting use to specialized opioid treatment programs (OTPs).4 This effort has yielded two important products that the Food and Drug Administration (FDA) has approved for use in treating an opioid use disorder and/or preventing relapse: buprenorphine (alone and in combination with naloxone) and naltrexone (in an oral formulation and an extended-release injectable formulation). These medications differ in mechanism of action, route and frequency of administration, and certain regulatory restrictions on their use as shown in Table 1 on page 4.

After reviewing multiple studies, many experts in addiction have concluded that patients who have an opioid use disorder should be offered medication-assisted treatments on a routine basis.5 However, considerable resistance to the use of such treatments persists. A diagnosis of opioid use disorder continues to carry significant social bias, which affects both the individuals who receive the diagnosis and the health care professionals to whom such individuals may turn for care.*6

With practical resources, the unmet need for treatment and the largely untapped resource of primary care medicine can be brought together to yield healthier patients who are treated in safer environments and an expanded repertoire of effective professional practices for primary care providers. In fact, many studies show that the treatment of an opioid use disorder can be successfully integrated into general office practice by physicians and health providers who are not addiction specialists.7–15

To review the options available for the treatment of opioid use disorder, the Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Institute on Drug Abuse (NIDA) jointly convened the Consensus Panel on New Pharmacotherapies for Opioid Use Disorders and Related Comorbidities (see Appendix A). Composed of experts in research, clinical care, medical education, and public policy, the panel reviewed current evidence on the effectiveness of available medications for the treatment of an opioid use disorder and developed a guidance for clinical practice.5

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Most up to date version available directly from SAMHSA.

Pub id: SMA14-4892
Publication Date: 12/2014
Last Reviewed: 01/05/2015
Popularity: Not ranked
Format: Guidelines or Manual
Audience: Professional Care Providers
Population Group: Patients

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