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 ResearchMeSH KeywordsAnalgesics, OpioidBuprenorphineClinical Trials as TopicHumansOpiate Substitution TreatmentOpioid-Related DisordersQuality of LifeConceptsOpioid 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
2020
The state of clinical outcome assessments for cannabis use disorder clinical trials: A review and research agenda
Loflin MJE, Kiluk BD, Huestis MA, Aklin WM, Budney AJ, Carroll KM, D'Souza DC, Dworkin RH, Gray KM, Hasin DS, Lee DC, Le Foll B, Levin FR, Lile JA, Mason BJ, McRae-Clark AL, Montoya I, Peters EN, Ramey T, Turk DC, Vandrey R, Weiss RD, Strain EC. The state of clinical outcome assessments for cannabis use disorder clinical trials: A review and research agenda. Drug And Alcohol Dependence 2020, 212: 107993. PMID: 32360455, PMCID: PMC7293929, DOI: 10.1016/j.drugalcdep.2020.107993.Peer-Reviewed Original ResearchMeSH KeywordsAdultBiomedical ResearchClinical Trials as TopicFemaleHumansMaleMarijuana AbuseMotivationPatient Outcome AssessmentSelf ReportConceptsClinical outcome assessmentCannabis use disorderClinical trialsOutcome assessmentForms of cannabisCannabis-related harmsCannabis reductionPrimary outcomeFunctional outcomeInterpretation of outcomesClinical endpointsNew pharmacotherapiesPsychomotor impairmentOutcome measuresSelf-report assessmentsDiagnostic criteriaUse disordersOptimal durationCannabis useStudy designBiologic assaysTrialsOptimal outcomesLack of consensusCannabis
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
2014
Toward empirical identification of a clinically meaningful indicator of treatment outcome: Features of candidate indicators and evaluation of sensitivity to treatment effects and relationship to one year follow up cocaine use outcomes
Carroll KM, Kiluk BD, Nich C, DeVito EE, Decker S, LaPaglia D, Duffey D, Babuscio TA, Ball SA. Toward empirical identification of a clinically meaningful indicator of treatment outcome: Features of candidate indicators and evaluation of sensitivity to treatment effects and relationship to one year follow up cocaine use outcomes. Drug And Alcohol Dependence 2014, 137: 3-19. PMID: 24556275, PMCID: PMC4042667, DOI: 10.1016/j.drugalcdep.2014.01.012.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsClinical Trials as TopicCocaine-Related DisordersEmpirical ResearchFollow-Up StudiesHumansQuality Indicators, Health CareTreatment Outcome