dations for research in this emerging field. Specifically, the committee was charged with identifying and defining distinctive behavioral, ethical, legal, and social issues that are likely to arise if and when these medications become available for treating drug addiction. Such issues can be considered unique aspects of safety and efficacy that are fundamentally related to the distinct nature and properties of these new types of medications. The committee was not charged with determining whether or not immunotherapies and sustained-release formulations represented an efficacious approach for treating drug addiction. Nor was it asked to determine whether or not NIDA should continue to fund research on these types of therapies. Rather, the committee was charged with identifying and defining issues that are likely to arise if and when these medications become available. Essentially, the committee was charged with formulating a research agenda. The result of that work is presented herein. This research agenda has been informed by a series of commissioned papers, comments when these papers were presented at a public workshop, and the expertise and judgment of the committee.

BASIC IMMUNOLOGY

The committee examined three different types of therapeutic agents: active immunotherapies, passive immunotherapies, and depot formulations of opioid antagonists. Active immunotherapies use periodic injections to stimulate the body’s own protective immune system to generate antidrug antibodies, which then bind drugs of abuse in the bloodstream before they can reach the brain. Passive immunotherapies use preformed antidrug monoclonal antibodies that are produced through advanced biotechnology techniques; they also bind drugs of abuse in the bloodstream and can be infused for immediate treatment for drug overdose. Depot medications are long-acting formulations of existing drugs that are slowly released over time, typically administered as injections.

To date, the new medications have been studied primarily for their efficacy in the treatment of drug dependence, chronic drug use, and drug overdose. It is plausible that they will prove efficacious in protecting against initiation and escalation of drug use. However, the immunotherapies are still quite new, and there is very limited research. The research to date suggests that the concept might work, but that limited research does not constitute evidence that this therapeutic approach or any particular new molecular entity is safe or efficacious. Although there is much more research on depot medications against opiate addiction, the committee was also not charged with a review of the safety or efficacy of depot medications.

Immunotherapy and depot medications can block or significantly



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