Psychopharmacology
-
Review
Ethical considerations in psychopharmacological research involving decisionally impaired subjects.
Research subjects who are unable to provide informed consent must be protected from exploitation. The federal regulations governing human subjects research mandate additional protections for "mentally disabled" subjects but include neither a definition of this "vulnerable" population nor any guidance on what safeguards should be employed or how they should be implemented. ⋯ Clinical investigators and IRBs are under considerable scrutiny with respect to the protection of decisionally impaired research subjects. There is a pressing need for data-driven strategies for the optimal protection of decisionally impaired research subjects.
-
Optimizing the abilities of individuals with psychiatric disorders to provide meaningful informed consent for research has become a heightened concern for psychiatric researchers. ⋯ Problem areas in the understanding of informed consent, such as study procedures and potential risks and benefits, should be the focus of attempts to improve the consent process for patient participants with severe mental illness. Research also should be done to clarify how best to assess understanding of consent, since the wording of questions likely affects the responses.
-
The numbers of older persons with psychiatric disorders are expected to rise rapidly in coming decades, yet most studies of the safety and efficacy of treatments for such disorders have focused on younger adults. A substantial expansion in research involving older patients is needed to meet the treatment needs of this fast growing group. A critical issue in intervention research is ensuring a patient's decision-making capacity. Considerable heterogeneity exists in this regard even within diagnostic groups. Cognitive changes as well as increased complexity of medication regimens in elderly patients may make it particularly difficult for some older persons to fully understand, appreciate, and/or reason about the risks and benefits of participating in any particular study. ⋯ The decisional capacity for a given research protocol is not necessarily an unmodifiable trait, but can be enhanced with improvements in consenting procedures, even in older persons with psychotic disorders.
-
Randomized Controlled Trial Clinical Trial
Characterizing the subjective, psychomotor, and physiological effects of oral oxycodone in non-drug-abusing volunteers.
The subjective, psychomotor, and physiological effects of a widely prescribed and abused prescription opioid, oxycodone, have not been studied in a population of non-drug-abusing people. ⋯ Oxycodone produced effects similar to those of other mu opioid agonists. Although oxycodone produced abuse liability-related subjective effects, it also produced unpleasant effects, a phenomenon we have observed in other opioid studies in non-drug-abusing volunteers.