lofexidine (Rawson et al., 2000) to treat nicotine addiction are currently being developed. All three therapies—vaccines, monoclonal antibodies, and sustained-release formulations—are long acting, but time limited, with durations from weeks to months.

The availability of these medications will raise a host of issues. Some of these issues will marry traditional vaccine concerns, such as establishing and monitoring safety, ensuring efficacy, and financing and distributing the medications, with traditional drug abuse treatment issues, such as ensuring patient adherence to treatment, using these therapies in a variety of settings, and dealing with coercive legal methods that are sometimes used to “motivate” treatment initiation. In addition, less traditional issues may also be raised, such as who should be immunized or treated with a depot medication and when, and who will decide.


NIDA requested the advice of the National Research Council and the Institute of Medicine of the National Academies about behavioral, ethical, legal, and social issues likely to arise as a result of research they are funding to develop immunotherapies and sustained-release formulations. The Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction was formed to identify and define the behavioral, ethical, legal, and social questions that will be raised in determining who should be given these medications and under what circumstances, given the major issue of therapeutic safety. This study was not intended to be a safety review of immunotherapies and sustained-release formulations, which are still under development, but safety forms a necessary backdrop for all of the issues the committee considered. Morover, the committee was not asked to evaluate the actual or potential efficacy of immunotherapies and depot medications for treating drug addiction. These therapies are still under development, and none has even been submitted to the Food and Drug Administration (FDA) for approval.

The committee was not expected to achieve consensus about how all of the issues should be resolved. Rather, the committee was expected to achieve consensus about what the issues are likely to be and which are likely to be the most pressing Indeed, the committee was charged with anticipating issues that may or may not bear upon the assessment of safety and efficacy of these medications. The committee has attempted to forecast issues that may arise in the therapeutic use of these medications if and when they are approved by the FDA for use. The committee believes that the nature and importance of many of these issues are such that NIDA may wish to encourage research into these issues in parallel with—if not integrated into—clinical trials that are done in order to test and demon-

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