Serious adverse events in randomized psychosocial treatment studies: Safety or arbitrary edicts?
Open accessAbstract
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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Factors that limit MBI trials involving UEs include difficulty obtaining a statistically significant number of participants and the type of design of these studies.
“In addition to these possible flaws, factors that limit MBI trials involving UEs include the difficulty associated with obtaining a statistically significant number of participants and the type of design of these studies [6, 27, 28].”
From Unwanted effects: is there a negative side of meditation? A multicentre survey (2017) · cites this paper as [28]
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References 24 · Cited by 44
Research works printed but not linked: 2
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 ICH harmonized tripartite guideline Accessed at http://www.fda.gov/cder/guidance/959fnl.pdf December 2, 2006
- Mays D Frank C 1985 Negative outcomes in psychotherapy New York Springer
- Authors
- 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.
- Affiliations
- UConn Health (US)
- Washington State University Spokane (US)
- Yale University (US)
- Johns Hopkins University (US)
- National Institute on Drug Abuse (US)
- Treatment Research Institute (US)
- Oregon Health & Science University (US)
- ORCID
- Venue
- Journal of Consulting and Clinical Psychology
- Published
- 2008
- Volume
- 76
- Issue
- 6
- Pages
- 1076-1082
- ISSN
- 0022-006X (ISSN-L)
- 1939-2117
- PMC
- PMC2756150
- OpenAlex
- W2045821753
- Cited by
- 44
- References
- 24
- Citations by year
- 2025: 2 · 2024: 10 · 2023: 1 · 2021: 1 · 2020: 2 · 2019: 2 · 2018: 2 · 2017: 4 · 2014: 5 · 2013: 1 · 2012: 1
- FWCI
- 4.31
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Consulting and Clinical Psychology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Drug Abuse (DA13034; DA13036; DA13038; DA13046; DA13716)
- National Institutes of Health (R01-DA13444; R01-DA018883; R01-DA016855; R01-DA14618; R01-DA021567; R01-DA022739; R01-MH60417; P50-DA09241; P60-AA03510)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- serious adverse events, addiction treatment, contingency management, motivation enhancement, research participant protection, treatment safety monitoring
- MeSH terms
- Adult, Counseling, Female, Follow-Up Studies, Heroin Dependence, Humans, Male, Methadone, Middle Aged, Narcotics, Patient Acceptance of Health Care, Psychology, Psychotherapy, Severity of Illness Index, Sex Factors, Incidence, Drug-Related Side Effects and Adverse Reactions
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