Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts?

Nancy M. Petry, John M. Roll, Bruce J. Rounsaville, Samuel A. Ball, Maxine Stitzer, Jessica M. Peirce, Jack Blaine, Kimberly C. Kirby, Dennis McCarty, Kathleen M. Carroll

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23 Scopus citations

Abstract

Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance-abusing participants (N = 1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced 1 or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the data safety monitoring board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials.

Original languageEnglish (US)
Pages (from-to)1076-1082
Number of pages7
JournalJournal of Consulting and Clinical Psychology
Volume76
Issue number6
DOIs
StatePublished - Dec 1 2008

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Keywords

  • good clinical practice
  • human subjects protection
  • participant safety
  • psychosocial treatments
  • serious adverse events

ASJC Scopus subject areas

  • Clinical Psychology
  • Psychiatry and Mental health

Cite this

Petry, N. M., Roll, J. M., Rounsaville, B. J., Ball, S. A., Stitzer, M., Peirce, J. M., Blaine, J., Kirby, K. C., McCarty, D., & Carroll, K. M. (2008). Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts? Journal of Consulting and Clinical Psychology, 76(6), 1076-1082. https://doi.org/10.1037/a0013679