. "Appendix B: What Will We Learn from the FDA Clinical Trials Process and What Will We Still Want to Know About Immunotherapies and Depot Medications to Treat Drug Dependence?." New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions. Washington, DC: The National Academies Press, 2004.
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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions
tical issues, such as the cost of such a long-term study in even a relatively high-risk group.
Protection protocols also are likely to be aimed at adolescents, since it is during adolescence that the majority of experimentation with substances is initiated and the potential for protection is greatest. However, protection protocols in adolescents may have three broad risks. First, they may result in medical harm to the adolescent, which will be covered in this appendix. Second, there may be psychological or social harm to the child-parent relationship resulting from parents “forcing” their adolescents to get treatments against their will or in a manner that harms parent-child trust. Third, there may be a misplaced biological focus for any antagonist protection in adolescents where much of the incentive to use illicit drugs or even tobacco is related to social, not pharmacological, effects. Adolescents want to impress peers, demonstrate rebelliousness to their parents, signal membership in a clique or subculture, and generally assert a social message. Pharmacological reinforcement of a drug may be a secondary motivation for use. Consequently, inhibiting this pharmacological reinforcement will have little effect on such motivations to use the substance and be much less cost effective than alternative protection strategies.
A typical overdose protocol might use monoclonal antibodies to reverse an acute overdose of a drug such as PCP (Owens and Mayershohn, 1986; Valentine et al., 1996). However, since monoclonal antibodies can last up to several months, it is important that safety be considered in two areas (Proksch, Gentry, and Owens, 2000). First, if an individual is dependent on the overdosed substance, withdrawal will occur after the overdose is reversed, and this withdrawal will not be suppressed by treatment with the usual modest doses of a long-acting agonist from the same pharmacological class as the targeted overdose drug. Very large doses of the agonist might be required to overcome the antagonism produced by the antibody treatment. Second, when the patient who has recovered from the overdose leaves the emergency department, he or she will continue to have a relative blockade of the abused substance. Any attempts by the patient to override this blockade could lead to the use of large amounts of an abused substance. The effects of any adulterants included in an illicit street drug would be magnified by this more intensive self-administration. Thus only a single dose of the medication would be needed to provide acute treatment, but aftercare would be critical because of the potential for the intervention to be long lasting. Using monoclonal fragments (Fab) rather than the complete humanized antibodies will be an impor-