2024
Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement
Lee B, Witkiewitz K, Mellinger J, Anania F, Bataller R, Cotter T, Curtis B, Dasarathy S, DeMartini K, Diamond I, Diazgranados N, DiMartini A, Falk D, Fernandez A, German M, Kamath P, Kidwell K, Leggio L, Litten R, Louvet A, Lucey M, McCaul M, Sanyal A, Singal A, Sussman N, Terrault N, Thursz M, Verna E, Radaeva S, Nagy L, Mitchell M. Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement. Nature Reviews Gastroenterology & Hepatology 2024, 21: 626-645. PMID: 38849555, DOI: 10.1038/s41575-024-00936-x.Peer-Reviewed Original ResearchAlcohol-associated liver diseaseAlcohol use disorderLiver diseaseClinical trialsRisk of decompensation of liver diseaseAlcohol useUse disorderTreatment of alcohol use disordersExpert panel consensus statementDecompensation of liver diseaseAddiction medicine specialistsProgression of liver diseaseLiver-related outcomesNational Institute of Alcohol AbuseDesigning clinical trialsEffects of alcohol useConsensus of expert opinionTask ForceConsensus statementMedicine specialistsAlcohol abuseHeavy drinkingDiseaseClinical trialistsPatients
2021
73936 Developing a Patient-Rated Outcome Measure of Alcohol and Drug Craving: A Systematic Review
Haeny A, Morean M, DeMartini K, Funaro M, O’Malley S. 73936 Developing a Patient-Rated Outcome Measure of Alcohol and Drug Craving: A Systematic Review. Journal Of Clinical And Translational Science 2021, 5: 39-39. PMCID: PMC8827664, DOI: 10.1017/cts.2021.505.Peer-Reviewed Original ResearchPatient-rated outcome measuresOutcome measuresSystematic reviewClinical trialsDrug useStimulant usePatient rated outcome measuresSubstance use disordersEffective treatmentPRISMA guidelinesUse disordersElectronic databasesDrug cravingPotential targetOpioidsCravingFDANicotineTrialsDisordersResults/CannabisReviewFindingsMedications
2016
Urgency traits moderate daily relations between affect and drinking to intoxication among young adults
Bold KW, Fucito LM, DeMartini KS, Leeman RF, Kranzler HR, Corbin WR, O’Malley S. Urgency traits moderate daily relations between affect and drinking to intoxication among young adults. Drug And Alcohol Dependence 2016, 170: 59-65. PMID: 27875802, PMCID: PMC5183550, DOI: 10.1016/j.drugalcdep.2016.10.035.Peer-Reviewed Original ResearchConceptsYoung adultsHeavy drinkingEffectiveness of naltrexoneBlood alcohol concentrationHeavy drinking young adultsBrief motivational interventionNaltrexone treatmentClinical trialsHazardous drinkingNaltrexoneSecondary analysisPlaceboTargeted interventionsAge 18Alcohol useIntoxicationLow urgencyAdultsMotivational interventionDrinkingTrait urgencyOddsInterventionCurrent studyRiskDaily Relations Among Affect, Urge, Targeted Naltrexone, and Alcohol Use in Young Adults
Bold KW, Fucito LM, Corbin WR, DeMartini KS, Leeman RF, Kranzler HR, O’Malley S. Daily Relations Among Affect, Urge, Targeted Naltrexone, and Alcohol Use in Young Adults. Experimental And Clinical Psychopharmacology 2016, 24: 367-375. PMID: 27690505, PMCID: PMC5111359, DOI: 10.1037/pha0000090.Peer-Reviewed Original ResearchConceptsYoung adultsDouble-blind clinical trialHeavy drinkingSerious public health problemDose of medicationPublic health problemAlcohol-related interventionsTargeted naltrexoneNaltrexone groupOpioid antagonistRisk factorsClinical trialsFamily historyNaltrexone effectsGreater oddsAlcohol consumptionHealth problemsAlcohol dependenceSecondary analysisPlaceboNaltrexoneNaltrexone's abilityAdultsMedicationsDrinking
2015
Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety.
O'Malley SS, Corbin WR, Leeman RF, DeMartini KS, Fucito LM, Ikomi J, Romano DM, Wu R, Toll BA, Sher KJ, Gueorguieva R, Kranzler HR. Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety. The Journal Of Clinical Psychiatry 2015, 76: e207-13. PMID: 25742208, PMCID: PMC4442987, DOI: 10.4088/jcp.13m08934.Peer-Reviewed Original ResearchConceptsHeavy drinking daysBlood alcohol concentrationPercent days abstinentDrinking daysNumber of drinksYoung adultsDays abstinentPercent heavy drinking daysOutpatient research centerSafety of naltrexonePlacebo-controlled studySerious adverse eventsRisk-benefit ratioPercentage of daysAdverse eventsSecondary outcomesPrimary outcomeFrequency of drinkingOpioid antagonistAdult heavy drinkersAlcohol drinkingClinical trialsEvaluable samplesYoung adult heavy drinkersTreatment period