tion and a legally authorized representative or guardian is also not available to provide the informed consent. In this circumstance, FDA regulations allow for a community consultation process whereby researchers solicit opinions and input from representatives of the community in which the research will be done and from which subjects will be drawn. This consultative process can serve as a form of community consent for procedures being tested to treat emergency conditions when neither the subjects or their legally authorized representative is available to give individual, informed consent.

Prevention Studies

None of the phase III studies is likely to address issues relevant to the prophylaxis of addiction in nonabusers (primary prevention) because of the substantial cost and long duration of this type of clinical trial to establish safety and efficacy. Nevertheless, subjects with sustained abstinence, who are at high risk for relapse, might be approached for secondary prevention studies during phase IV monitoring. Four issues will be important for these prevention studies: the nature of the study population, the range of agents tested, the targeting of multiple therapeutic targets or integration with existing treatments, and the use of a variety of settings where testing and treatment are provided. The issue of where to conduct treatment may be a particular challenge, because many substance abuse treatment programs lack the medical infrastructure to deliver pharmacotherapies. In the past, coordination between substance abuse treatment programs and medical settings has not been very successful, as we describe in Chapter 3.

Off-Label Uses

As noted above, many ethical issues will arise as off-label uses of these immunotherapies or depot medications proliferate in the postapproval period. New populations may be studied, including adolescents, prisoners, and pregnant women, and new treatment settings, such as primary-care medical clinics, may be examined. The FDA testing process will provide only limited help in generalizing to off-label uses, and the extent to which the process will help will vary across the specific abused substances.

Off-label uses in medical settings are likely to be provided most effectively for nicotine products but much more poorly for cocaine, amphetamines, and PCP. The difficulties with services for the latter drugs include limited information on their use from the pivotal trials (e.g., the reversal of overdose using monoclonal antibodies for PCP), need for close coordination with substance abuse treatment settings that have limited



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