2023
Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder
Kiluk B, Kleykamp B, Comer S, Griffiths R, Huhn A, Johnson M, Kampman K, Pravetoni M, Preston K, Vandrey R, Bergeria C, Bogenschutz M, Brown R, Dunn K, Dworkin R, Finan P, Hendricks P, Houtsmuller E, Kosten T, Lee D, Levin F, McRae-Clark A, Raison C, Rasmussen K, Turk D, Weiss R, Strain E. Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder. JAMA Psychiatry 2023, 80: 84-92. PMID: 36449315, PMCID: PMC10297827, DOI: 10.1001/jamapsychiatry.2022.4020.Peer-Reviewed Original ResearchConceptsOpioid use disorderOUD treatmentUse disordersClinical trial design challengesAddiction Clinical Trial TranslationsΜ-opioid receptor systemNetworks (ACTTION) public-private partnershipTrial design challengesOngoing opioid epidemicTrial design considerationsClinical trial design considerationsRole of treatmentQuality of lifeAntagonist medicationsEmerging TreatmentsAdverse eventsOpioid usePrimary outcomeStages of treatmentPatient preferencesMOR agonistsOpioid epidemicConsensus recommendationsCurrent evidenceTreatment retention
2015
Measures of outcome for stimulant trials: ACTTION recommendations and research agenda
Kiluk BD, Carroll KM, Duhig A, Falk DE, Kampman K, Lai S, Litten RZ, McCann DJ, Montoya ID, Preston KL, Skolnick P, Weisner C, Woody G, Chandler R, Detke MJ, Dunn K, Dworkin RH, Fertig J, Gewandter J, Moeller FG, Ramey T, Ryan M, Silverman K, Strain EC. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda. Drug And Alcohol Dependence 2015, 158: 1-7. PMID: 26652899, PMCID: PMC4698050, DOI: 10.1016/j.drugalcdep.2015.11.004.Peer-Reviewed Original ResearchConceptsStimulant use disorderClinical trialsMeaningful outcome measuresUse disordersTreatment successOutcome measuresStimulant abstinenceAddiction Clinical Trial TranslationsFuture clinical trialsClinical trial endpointsClinical trial dataAlcohol use disorderMeasures of outcomeValidation of PatientStimulant trialsTrial endpointsEfficacious pharmacotherapiesUrine testingSustained abstinenceTrial dataSecondary analysisStimulant useTrialsPsychosocial benefitsDisorders