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Ethical Considerations of Biologics to Treat Substance Use Disorders

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Biologics to Treat Substance Use Disorders

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Abstract

The development of biologic products to treat substance use disorders (SUDs) poses important and sometimes unique ethical challenges due to the clinical characteristics of patients with the disorders and the nature of these products. Historically, there has been a great deal of discussion about the ethics of conducting clinical research in individuals with SUDs. They include the stigma associated with drug abuse, the legal issues associated with disclosing the use of illicit drugs, and the protection of subject’s confidentiality from disclosure of potentially harmful information. Moreover, the behavioral manifestations associated with SUDs, which often include chaotic lifestyles, may hinder recruitment and retention of subjects in clinical studies, study protocol adherence, and reliability of self-reported data (Cohen 1997). Recently, biologics such as vaccines, monoclonal antibodies, and enzymes have been investigated to treat SUDs because they prevent the access of drugs of abuse to the brain, attenuate their rewarding effects, and protect against drug use relapse. Currently, there are no biologics approved by the Food and Drug Administration (FDA) for any SUDs. New products, as well as new and more efficient methods of production, are offering vast opportunities to advance the discovery and development of biologics to treat SUDs and drug overdose. The purpose of this chapter is to provide an overview of some ethical issues of clinical studies of SUDs, each of type of the biologic product, and the clinical indications being investigated.

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Authors and Affiliations

  1. Division of Therapeutics and Medical Consequences of Drug Abuse, National Institute on Drug Abuse, Bethesda, MD, USA

    Ivan D. Montoya MD, MPH

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  1. Ivan D. Montoya MD, MPH
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Correspondence to Ivan D. Montoya MD, MPH .

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  1. National Institute on Drug Abuse, National Institutes of Health, Bethesda, USA

    Ivan D. Montoya

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Montoya, I.D. (2016). Ethical Considerations of Biologics to Treat Substance Use Disorders. In: Montoya, I. (eds) Biologics to Treat Substance Use Disorders. Springer, Cham. https://doi.org/10.1007/978-3-319-23150-1_21

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  • DOI: https://doi.org/10.1007/978-3-319-23150-1_21

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-23149-5

  • Online ISBN: 978-3-319-23150-1

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