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Executive Summary
Pages 1-6

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From page 1...
... Despite their potential benefits, however, several characteristics of these new methods pose distinctive behavioral, ethical, legal, and social challenges that require careful scrutiny. At the request of and with support from the National Institute on Drug Abuse (NIDA)
From page 2...
... 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.
From page 3...
... Another important characteristic of these medications is that they have long durations of action -- a month or even longer per administration -- which should reduce the problem of nonadherence found with medications that must be taken daily. Recommendation 1 The National Institute on Drug Abuse should support basic immunology studies on increasing the stability and longevity of antibody blood levels and on developing combination therapies to simultaneously treat a variety of abused drugs.
From page 4...
... The effects of immunotherapies on false-positive and false-negative drug testing results should also be studied. Recommendation 5 The National Institute on Drug Abuse should support clinical effectiveness studies and financing models that integrate the new pharmacotherapies with psychosocial services in specialty addiction and primary medical care settings.
From page 5...
... Recommendation 6 The National Institute on Drug Abuse should support studies of behavioral consequences, such as the increased potential for accidental overdose and changes in drug use patterns, which may include switching drugs, increasing drug dosage or over all consumption, changing the route of administration (e.g. nasal to intravenous for greater bioavailability)
From page 6...
... Recommendation 9 The National Institute on Drug Abuse should support studies to determine the standards to be applied when immunotherapy medications are considered for use in the criminal justice and child welfare systems including due process protections when there is a government-imposed treatment requirement. Recommendation 10 The National Institute on Drug Abuse should support studies to carefully articulate the behavioral, ethical, and social risks associated with treatment of pregnant women and their fetuses and protective therapy in minors and to develop clinical practice guidelines for such use or discouragement of such use.


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