Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts?
Petry NM, Roll JM, Rounsaville BJ, Ball SA, Stitzer M, Peirce JM, Blaine J, Kirby KC, McCarty D, Carroll KM. Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts? Journal Of Consulting And Clinical Psychology 2008, 76: 1076-1082. PMID: 19045975, PMCID: PMC2756150, DOI: 10.1037/a0013679.Peer-Reviewed Original ResearchMeSH KeywordsAdultCounselingDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHeroin DependenceHumansIncidenceMaleMethadoneMiddle AgedNarcoticsPatient Acceptance of Health CarePsychologyPsychotherapySeverity of Illness IndexSex FactorsConceptsSerious adverse eventsAdverse eventsStandard careDrug Abuse Clinical Trials NetworkMore (95% CI 4 to 167 more) serious adverse eventsSAE incidence rateClinical Trials NetworkPsychosocial treatment studiesPsychosocial intervention studiesPercent of participantsPsychosocial trialsIncidence ratePharmaceutical trialsTherapy trialsIntervention studiesTreatment studiesTrials NetworkHuman subjects protection policiesSubstance-abusing participantsContingency managementMotivational enhancementNational InstituteTrialsSignificant differencesCare