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Antagonists in the Medical Management of Opioid Use Disorders: Historical and Existing Treatment Strategies

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Antagonists in the Medical Management of Opioid Use Disorders: Historical and Existing Treatment Strategies The American Journal on Addictions, 27: 177–187, 2018 © 2018 The Authors. The American Journal on Addictions Published by Wiley Periodicals, Inc. on behalf of The American Academy of Addiction Psychiatry (AAAP) ISSN: 1055-0496 print / 1521-0391 online DOI: 10.1111/ajad.12711 Antagonists in the Medical Management of Opioid Use Disorders: Historical and Existing Treatment Strategies Adam Bisaga, MD ,1 Paolo Mannelli, MD ,2 Maria A. Sullivan, MD, PhD,1,3 Suzanne K. Vosburg, PhD,4 Peggy Compton, PhD, RN,5 George E. Woody, MD,6 Thomas R. Kosten, MD7 1Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, New York 2Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina 3Alkermes Inc., Waltham, Massachusetts 4Scientific Consultant, Edgewater, New Jersey 5Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 6Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 7Baylor College of Medicine, Houston, Texas Background and Objectives: Opioid use disorder (OUD) is a Journal on Addictions Published by Wiley Periodicals, Inc. on behalf of chronic condition with potentially severe health and social The American Academy of Addiction Psychiatry (AAAP);27:177–187) consequences. Many who develop moderate to severe OUD will repeatedly seek treatment or interact with medical care via emergency department visits or hospitalizations. Thus, there is an urgent need to develop feasible and effective approaches to help persons with OUD INTRODUCTION achieve and maintain abstinence from opioids. Treatment that A drug overdose crisis exists in the United States, with the includes one of the three FDA-approved medications is an evidence- > based strategy to manage OUD. The purpose of this review is to majority ( 60%) of deaths involving an opioid such as heroin, 1 address practices for managing persons with moderate to severe OUD fentanyl, and carfentanil. The 2016 National Survey on Drug with a focus on opioid withdrawal and naltrexone-based relapse- Use and Health survey indicated that, within the past year, prevention treatment. approximately 2 million Americans aged 18 or older had an Methods: Literature available on PubMed was used to review the opioid use disorder (OUD) involving prescription pain relievers evolution of treatment strategies from the 1960s onward to manage 2 opioid withdrawal and initiate treatment with naltrexone. or heroin. OUD is a chronic and relapsing condition with Results: Emerging practices for extended-release naltrexone induction severe health, social, and societal consequences; many who include the use of agonist tapers and adjuvant medications. Clinical develop it repeatedly seek treatment or interact with medical challenges frequently encountered when initiating this therapy include care via emergency department visits or hospitalizations for managing withdrawal and ongoing opioid use during treatment. Clinical infections, overdoses, or other substance-related complications. factors may inform decisions regarding patient selection and length of fi naltrexone treatment, such as recent opioid use and patient preferences. Moderate to severe OUD as de ned by the Diagnostic and Conclusions and Scientific Significance: Treatment strategies to Statistical Manual of Mental Disorders (Fifth Edition) manage opioid withdrawal have evolved, but many patients with OUD (DSM-5)3 roughly corresponds to opioid dependence as defined do not receive medication for the prevention of relapse. Clinical by the DSM-IV4 and will be addressed in this review. strategies for induction onto extended-release naltrexone are now Extensive evidence reveals that pharmacotherapy with an available and can be safely and effectively implemented in specialty and select primary care settings. (© 2018 The Authors. The American opioid receptor agonist (methadone), partial agonist (buprenorphine), or long-acting injection formulation of the This is an open access article under the terms of the Creative opioid antagonist naltrexone (XR-NTX) improves outcomes Commons Attribution-NonCommercial License, which permits use, in patients treated for OUD. The most common treatment distribution and reproduction in any medium, provided the original approach to OUD involves opioid cessation and management work is properly cited and is not used for commercial purposes. of opioid withdrawal, typically a week-long process also Received September 8, 2017; revised March 2, 2018; accepted known as “detoxification,” followed by relapse-prevention March 3, 2018. Address correspondence to Dr. Bisaga, Department of Psychiatry, psychosocial therapy in residential or outpatient settings, with New York State Psychiatric Institute, Columbia University College of encouragement to participate in self-help groups. Psychosocial Physicians and Surgeons, 1051 Riverside Dr., Unit #120, New York, therapy helps patients adopt healthier nondrug-using life- NY 10032. styles, with medications providing further symptomatic E-mail: [email protected] support during this lengthy transition. 177 Although an approach that does not include medications to approximately 1 month after a single dose was FDA-approved for prevent relapse works for some patients (e.g., those treated in long- the prevention of relapse to opioid dependence following opioid term residential programs),5 evidence has repeatedly associated detoxification as part of an individualized comprehensive manage- this approach with high rates of relapse and complications, ment program that includes psychosocial support.12 including fatal overdose.6 Thus, clinical experts favor OUD This long-acting formulation can be given in a wide range of treatments that include maintenance medications because they are clinical settings, including primary care and criminal justice consistent with evidence and constitute adequate care.7,8 systems.13,14 However, there is limited experience with this drug Pharmacological management usually involves maintenance medication outside specialized treatment settings. XR-NTX has treatment with an opioid receptor agonist or a partial agonist, and frequently been offered to patients who have completed extended this approach has the most extensive evidence supporting its long- residential treatment15 and to patients for whom initiation of term effectiveness.7 An advantage of agonist treatment is that it can relapse-prevention treatment with XR-NTX was relatively be started in outpatients while minimizing the severity and uncomplicated because of current abstinence.16 Most patients in duration of opioid withdrawal. Both methadone and buprenor- need of treatment, however, are actively using opioids at the time of phine are listed by the World Health Organization (WHO) as initial evaluation and require completion of opioid withdrawal essential medications to treat OUD; in the United States, both are before XR-NTX initiation. Although medically supervised approved by the US Food and Drug Administration (FDA) for the management of withdrawal in the inpatient setting is optimal, the treatment of opioid dependence/addiction. Methadone and availability of inpatient treatment in the United States is limited and buprenorphine have been shown to increase adherence to where it exists is often restricted to a few days. Therefore, feasible antiretroviral therapy in HIV-infected drug users9 andtoincrease and effective outpatient approaches to manage opioid withdrawal treatment retention of opioid-dependent pregnant women.10 for patients seeking treatment with XR-NTX are needed. Recently, longer-acting formulations of buprenorphine have This review describes the evolution of treatment strategies to been developed, including a monthly injection. Additional manage opioid withdrawal and initiate treatment with XR-NTX, research is ongoing to evaluate an extended-release buprenorphine with a focus on the outpatient setting, and discusses emerging implant in Phase 3 randomized clinical trials.11 XR-NTX induction practices, challenges frequently encountered An alternative strategy involves treatment with an opioid receptor when initiating XR-NTX, and clinical factors helpful in antagonist such as naltrexone. Naltrexone administration requires identifying patients suitable for opioid antagonist treatment. prior completion of opioid withdrawal, typically with 7–10 days Literature available on PubMed was used to review the evolution having passed since the last opioid dose; otherwise, it may precipitate of treatment strategies from the 1960s onward to manage opioid significant opioid withdrawal. Oral naltrexone, a formulation that withdrawal and initiate treatment with naltrexone. requires daily administration, has been available for clinical use in the United States since the 1970s. It is recognized in WHO treatment guidelines for preventing relapse in patients who have withdrawn HISTORICAL PERSPECTIVE ON CLINICAL from opioids8 and is FDA-approved for the blockade of the effects of MANAGEMENT OF OPIOID WITHDRAWAL AND exogenously administered opioids. However, problems with INITIATING TREATMENT WITH NALTREXONE adherence to a daily medication regimen followed by treatment dropout have limited the effectiveness of oral naltrexone in clinical Medical management of OUD has continued to evolve practice. In 2010, an extended-release injectable naltrexone since the first widespread treatments were introduced in the (XR-NTX) formulation that
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