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

doi:10.1037/a0013679

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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34 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 language	English (US)
Pages (from-to)	1076-1082
Number of pages	7
Journal	Journal of Consulting and Clinical Psychology
Volume	76
Issue number	6
DOIs	https://doi.org/10.1037/a0013679
State	Published - Dec 2008
Externally published	Yes

All Science Journal Classification (ASJC) codes

Clinical Psychology
Psychiatry and Mental health

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10.1037/a0013679

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title = "Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts?",

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.",

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

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AU - Petry, Nancy M.

AU - Roll, John M.

AU - Rounsaville, Bruce J.

AU - Ball, Samuel A.

AU - Stitzer, Maxine

AU - Peirce, Jessica M.

AU - Blaine, Jack

AU - Kirby, Kimberly C.

AU - McCarty, Dennis

AU - Carroll, Kathleen M.

PY - 2008/12

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AB - 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.

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

Abstract

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