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

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Serious adverse events in randomized psychosocial treatment studies: Safety or Arbitrary Edicts?

Journal article

Open access

Peer reviewed

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 and Kathleen M Carroll

Journal of consulting and clinical psychology, Vol.76(6), pp.1076-1082

12/2008

DOI: https://doi.org/10.1037/a0013679

Handle:

https://hdl.handle.net/2376/107970

PMCID: PMC2756150

PMID: 19045975

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Abstract

serious adverse events

participant safety

behavioral therapy

substance abuse treatment

psychosocial treatments

human subjects protection

good clinical practice

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 one 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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Title: Serious adverse events in randomized psychosocial treatment studies: Safety or Arbitrary Edicts?
Creators: Nancy M Petry - Washington State University, Spokane, WA
John M Roll - Washington State University, Spokane, WA
Bruce J Rounsaville - Yale University and VA Connecticut, West Haven, CT
Samuel A Ball - Yale University and VA Connecticut, West Haven, CT
Maxine Stitzer - Johns Hopkins University, Baltimore, MD
Jessica M Peirce - Johns Hopkins University, Baltimore, MD
Jack Blaine - Medical consultant, National Institute on Drug Abuse, Rockville, MD
Kimberly C Kirby - Treatment Research Institute and University of Pennsylvania, Philadelphia, PA
Dennis McCarty - Oregon Health and Science University, Portland, OR
Kathleen M Carroll - Yale University and VA Connecticut, West Haven, CT
Publication Details: Journal of consulting and clinical psychology, Vol.76(6), pp.1076-1082
Academic Unit: Elson S. Floyd College of Medicine
Identifiers: 99900547135601842
Language: English
Resource Type: Journal article