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New Treatments for Addiction Behavioral, Ethical, Legal, and Social Questions (2004) / Chapter Skim
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2 Clinical Trials
Pages 16-22

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From page 16...
... . In all three kinds of tests, clinical trials subjects are likely to be adult males and nonpregnant adult females.
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From page 17...
... The committee believes that a diverse group of patients who need relapse prevention ought to be examined during the phase III testing process, before moving to protection protocols or special populations, such as pregnant women. Phase IV testing is used to monitor the use of a medication once it has been approved and is available for clinical practice.
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From page 18...
... NIDA and FDA Cooperation It will be important for NIDA and the FDA to work together to establish guidelines for testing and monitoring immunotherapy and depot medications in the general medical community, where off-label use is quite likely. Mechanisms for achieving this cooperation might include reconstituting the FDA Drug Abuse Advisory Committee and conducting joint workshops that involve consultants from outside NIDA and the FDA.
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From page 19...
... . Consequently, the committee believes that preclinical studies of these medications for use in pregnant women would provide the necessary safety data for use in all women, should the outcomes show acceptable safety profiles.
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From page 20...
... . If a trial involves the use of "emergency research" provisions in order to include patientsubjects who are not capable of providing informed consent, then advance approval by "community consultation" should include persons who are at risk of overdose and not simply community leaders who do not have any drug addiction problems.
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From page 21...
... 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)
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From page 22...
... Recommendation 2 Recognizing that immunotherapy medications will be used in off-label situations that have not been specifically approved by the Federal Drug Administration, the National Insti tute of Drug Abuse should support preclinical studies addressing the potential safety and efficacy of these medications when given to vulnerable populations (e.g., pregnant women and their fetus, ado lescents, etc.)
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Key Terms

  • pregnant women
  • informed consent
  • depot medications
  • phase iii
  • special populations

  • abuse treatment
  • fetal development
  • fda approval
  • ethical issues
  • substance abuse

  • drug abuse
  • consultative process
  • established mechanisms
  • preclinical studies
  • legally authorized

  • relapse prevention
  • commercial development
  • prevention studies
  • fetal exposure
  • immunotherapy medications

  • competent adults
  • providing informed
  • authorized representative
  • efficacy data
  • treatment programs

  • iii testing
  • monoclonal antibodies
  • establish safety
  • community consent
  • treatment settings


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