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Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts?

http://www.ncbi.nlm.nih.gov/pubmed/19045975

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.

Pubmed ID: 19045975 RIS Download

Mesh terms: Adult | Counseling | Drug-Related Side Effects and Adverse Reactions | Female | Follow-Up Studies | Heroin Dependence | Humans | Incidence | Male | Methadone | Middle Aged | Narcotics | Patient Acceptance of Health Care | Psychology | Psychotherapy | Severity of Illness Index | Sex Factors

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Associated grants

  • Agency: NIDA NIH HHS, Id: DA13034
  • Agency: NIDA NIH HHS, Id: DA13036
  • Agency: NIDA NIH HHS, Id: DA13038
  • Agency: NIDA NIH HHS, Id: DA13046
  • Agency: NIDA NIH HHS, Id: DA13716
  • Agency: NIDA NIH HHS, Id: P30 DA023918
  • Agency: NIDA NIH HHS, Id: P30 DA023918-01A1
  • Agency: NIDA NIH HHS, Id: P50 DA009241
  • Agency: NIDA NIH HHS, Id: P50 DA009241-06
  • Agency: NIDA NIH HHS, Id: P50-DA09241
  • Agency: NIAAA NIH HHS, Id: P60-AA03510
  • Agency: NIDA NIH HHS, Id: R01 DA013444
  • Agency: NIDA NIH HHS, Id: R01 DA013444-08
  • Agency: NIDA NIH HHS, Id: R01 DA016855
  • Agency: NIDA NIH HHS, Id: R01 DA016855-05
  • Agency: NIDA NIH HHS, Id: R01 DA018883
  • Agency: NIDA NIH HHS, Id: R01 DA018883-05
  • Agency: NIDA NIH HHS, Id: R01 DA021567
  • Agency: NIDA NIH HHS, Id: R01 DA021567-03
  • Agency: NIDA NIH HHS, Id: R01 DA022739
  • Agency: NIDA NIH HHS, Id: R01 DA022739-02
  • Agency: NIDA NIH HHS, Id: R01-DA016855
  • Agency: NIDA NIH HHS, Id: R01-DA018883
  • Agency: NIDA NIH HHS, Id: R01-DA021567
  • Agency: NIDA NIH HHS, Id: R01-DA022739
  • Agency: NIDA NIH HHS, Id: R01-DA13444
  • Agency: NIDA NIH HHS, Id: R01-DA14618
  • Agency: NIMH NIH HHS, Id: R01-MH60417
  • Agency: NIDA NIH HHS, Id: U10 DA013034
  • Agency: NIDA NIH HHS, Id: U10 DA013034-03
  • Agency: NIDA NIH HHS, Id: U10 DA013038

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