2021
Design of the national adaptive trial for PTSD-related insomnia (NAP study), VA cooperative study program (CSP) #2016
Krystal JH, Chow B, Vessicchio J, Henrie AM, Neylan TC, Krystal AD, Marx BP, Xu K, Jindal RD, Davis LL, Schnurr PP, Stein MB, Thase ME, Ventura B, Huang GD, Shih MC, Team T. Design of the national adaptive trial for PTSD-related insomnia (NAP study), VA cooperative study program (CSP) #2016. Contemporary Clinical Trials 2021, 109: 106540. PMID: 34416369, DOI: 10.1016/j.cct.2021.106540.Peer-Reviewed Original ResearchConceptsCooperative Studies ProgramInsomnia medicationsMedical CenterRandomized placebo-controlled clinical trialPlacebo-controlled clinical trialVeterans Affairs Medical CenterVA Cooperative Studies ProgramPrimary outcome measureVA Medical CenterInsomnia Severity IndexAdaptive trialsPosttraumatic stress disorderFuture biomarker developmentStudy armsBiochemical predictorsEffective pharmacotherapyClinical trialsOutcome measuresTreatment responseInterim analysisRecruitment targetInsomniaPhone contactStress disorderBiomarker development
1999
Assessment of the Safety and Efficacy Data for the Hypnotic Halcion(R): Results of an Analysis by an Institute of Medicine Committee
Gibbons R, Brown B, Azarnoff D, Bunney W, Cancro R, Gillin J, Hullett S, Killam K, Krystal J, Kupfer D, Stolley P, Pope A, French G. Assessment of the Safety and Efficacy Data for the Hypnotic Halcion(R): Results of an Analysis by an Institute of Medicine Committee. Journal Of The American Statistical Association 1999, 94: 993-1002. DOI: 10.1080/01621459.1999.10473852.Peer-Reviewed Original ResearchInstitute of MedicineEfficacy dataCurrent product labelingDuration of treatmentTreatment of insomniaPossible side effectsHypnotic effectivenessChronic insomniaSide effectsLow dosesAdult populationIOM reportMedicine CommitteeLabeling changesDifferent dosesU.S. FoodTask Force ReportDutch psychiatristsInsomniaProduct labelingDosesHalcionForce ReportPossible linkSafety