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

Journal of Consulting and Clinical Psychology 2008;76(6):1076-82. [doi: 10.1037/a0013679]

Nancy M. Petry, PhD (University of Connecticut Health Center, NE Node), John M. Roll, PhD (Washington State University, PN Node), Bruce J. Rounsaville, MD (Yale University School of Medicine, NE Node), Samuel A. Ball, PhD (Yale University School of Medicine, NE Node), Maxine L. Stitzer, PhD (Johns Hopkins University School of Medicine, MA Node), Jessica M. Peirce, PhD (Johns Hopkins University School of Medicine, MA Node), Jack D. Blaine, MD (NIDA Center for the Clinical Trials Network (CCTN)), Kimberly C. Kirby, PhD (Treatment Research Institute, DV Node), Dennis McCarty, PhD (Oregon Health & Science University, OR/HI Node), Kathleen M. Carroll, PhD (Yale University School of Medicine, NE Node).

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 (protocols CTN-0004, -0005, -0006, and -0007). 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. (Article (Peer-Reviewed), PDF, English, 2008)

Keywords: Adverse events | Behavior therapy | Contingency Management (CM) | CTN platform/ancillary study | Motivational Enhancement Therapy (MET) | Motivational incentives | Patient protections |Journal of Consulting and Clinical Psychology (journal)

Document No: 326, PMID: 19045975, PMCID: PMC2756150

Submitted by CTN Dissemination Librarians, 12/9/2008.


Ball, Samuel A. search mail
Blaine, Jack D. search mail
Carroll, Kathleen M. search mail
Kirby, Kimberly C. search
McCarty, Dennis search mail
Peirce, Jessica M. search
Petry, Nancy M. search mail
Roll, Samuel A. search mail
Rounsaville, Bruce J. search mail
Stitzer, Maxine L. search mail
NIDA-CTN-0004 search www
NIDA-CTN-0005 search www
NIDA-CTN-0006 search www
NIDA-CTN-0007 search www

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