2022
Viral Suppression Levels in Men Who Have Sex With Men and Transgender Women With Newly Diagnosed HIV and Alcohol Use Disorder in Peru: Results From a Randomized, Double-Blind, Placebo-Controlled Trial Using Oral Naltrexone
Gonzales P, Bachireddy C, Grieco A, Ding R, de Leon S, Ulrich A, Lama J, Duerr AC, Altice FL. Viral Suppression Levels in Men Who Have Sex With Men and Transgender Women With Newly Diagnosed HIV and Alcohol Use Disorder in Peru: Results From a Randomized, Double-Blind, Placebo-Controlled Trial Using Oral Naltrexone. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2022, 89: 462-471. PMID: 34897226, PMCID: PMC8881312, DOI: 10.1097/qai.0000000000002889.Peer-Reviewed Original ResearchConceptsMSM/transgender womenAlcohol use disorderOral naltrexoneTransgender womenViral suppressionUse disordersEFV/TDF/FTCTreatment of AUDMaximal viral suppressionSingle treatment regimenPlacebo-controlled trialTDF/FTCAntiretroviral therapy adherenceUse of naltrexoneEvidence-based treatmentsViral suppression levelsMVs levelsSecondary outcomesTherapy adherenceLow adherenceAdherence levelsNaltrexoneAUD treatmentHIVPlacebo
2020
Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy
Gonzales P, Grieco A, White E, Ding R, Ignacio RB, Pinto-Santini D, Lama JR, Altice FL, Duerr A. Safety of oral naltrexone in HIV-positive men who have sex with men and transgender women with alcohol use disorder and initiating antiretroviral therapy. PLOS ONE 2020, 15: e0228433. PMID: 32134956, PMCID: PMC7058313, DOI: 10.1371/journal.pone.0228433.Peer-Reviewed Original ResearchConceptsAlcohol use disorderAntiretroviral therapyClinical adverse eventsAdverse eventsTransgender womenUse disordersDouble-blind randomized placebo-controlled trialMSM/transgender womenRandomized placebo-controlled trialART-naïve participantsPossibility of hepatotoxicityPlacebo-controlled trialSerious adverse eventsHIV-positive menMedication-assisted therapyProportion of subjectsAdverse event dataMultiple new medicationsOral naltrexoneStudy medicationTransaminase elevationPlacebo armNTX treatmentTreatment armsNew medicationsAdherence to and Retention in Medications for Opioid Use Disorder Among Adolescents and Young Adults
Viera A, Bromberg DJ, Whittaker S, Refsland BM, Stanojlović M, Nyhan K, Altice FL. Adherence to and Retention in Medications for Opioid Use Disorder Among Adolescents and Young Adults. Epidemiologic Reviews 2020, 42: 41-56. PMID: 32239206, PMCID: PMC8087870, DOI: 10.1093/epirev/mxaa001.Peer-Reviewed Original ResearchConceptsOpioid use disorderUse disordersYoung adultsAssociation of ageFull-text reviewRetention of adolescentsConcurrent substance useNegative health outcomesMOUD retentionOpioid epidemicInclusion criteriaHealth outcomesYounger ageAge groupsMOUDSubstance useAdherenceGood evidenceAdultsMedicationsDisordersAdolescentsSearch criteriaAgeOutcomes
2019
Treating opioid dependence with extended-release naltrexone (XR-NTX) in Ukraine: Feasibility and three-month outcomes
Makarenko I, Pykalo I, Springer SA, Mazhnaya A, Marcus R, Filippovich S, Dvoriak S, Altice FL. Treating opioid dependence with extended-release naltrexone (XR-NTX) in Ukraine: Feasibility and three-month outcomes. Journal Of Substance Use And Addiction Treatment 2019, 104: 34-41. PMID: 31370983, PMCID: PMC8215516, DOI: 10.1016/j.jsat.2019.05.008.Peer-Reviewed Original ResearchConceptsOpioid use disorderOpioid agonist treatmentXR-NTX injectionXR-NTX treatmentXR-NTXUrine drug testingOpioid useExtended-release naltrexoneMonths of treatmentThree-month outcomeHealth-related qualityAdverse side effectsSymptoms of depressionOpioid dependenceAgonist treatmentLife scoresTreatment optionsIndependent factorsSide effectsUse disordersPeriod of observationDrug useStimulant useTreatment motivationDrug testing
2018
Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community
Springer SA, Di Paola A, Barbour R, Azar MM, Altice FL. Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2018, 79: 92-100. PMID: 29781884, PMCID: PMC6092223, DOI: 10.1097/qai.0000000000001759.Peer-Reviewed Original ResearchConceptsAlcohol use disorderViral suppressionExtended-release naltrexoneXR-NTXPlacebo groupPlacebo-controlled trialMonthly injectionsSecondary outcomesTreat analysisIncarcerated individualsEligible participantsWhite raceUse disordersAlcohol consumptionHIVMonthsNaltrexoneBaselineDisordersInjectionIncarcerated peopleParticipantsPlaceboGroupSuppressionExtended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community
Springer SA, Di Paola A, Azar M, Barbour R, Biondi BE, Desabrais M, Lincoln T, Skiest DJ, Altice FL. Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2018, 78: 43-53. PMID: 29373393, PMCID: PMC5889326, DOI: 10.1097/qai.0000000000001634.Peer-Reviewed Original ResearchMeSH KeywordsAdultCriminal LawDelayed-Action PreparationsDouble-Blind MethodFemaleFollow-Up StudiesHIV InfectionsHIV-1HumansInjections, IntramuscularMaleMiddle AgedMultivariate AnalysisNaltrexoneNarcotic AntagonistsOpioid-Related DisordersPrisonersProspective StudiesResearch DesignRNA, ViralTime FactorsTreatment OutcomeViral LoadConceptsOpioid use disorderViral suppressionXR-NTXPlacebo groupPrimary outcomeUse disordersXR-NTX groupPlacebo-controlled trialExtended-release naltrexoneStatistical significant differenceRelease naltrexoneMonthly injectionsEligible participantsTreatment groupsJail detaineesHIVMonthsBaselinePlaceboSignificant differencesNaltrexoneJail inmatesDisordersVS levelsOutcomesA qualitative assessment of attitudes about and preferences for extended-release naltrexone, a new pharmacotherapy to treat opioid use disorders in Ukraine
Marcus R, Bojko MJ, Mazhnaya A, Makarenko I, Filippovych S, Dvoriak S, Altice FL, Springer SA. A qualitative assessment of attitudes about and preferences for extended-release naltrexone, a new pharmacotherapy to treat opioid use disorders in Ukraine. Journal Of Substance Use And Addiction Treatment 2018, 86: 86-93. PMID: 29415856, PMCID: PMC5808584, DOI: 10.1016/j.jsat.2018.01.003.Peer-Reviewed Original ResearchConceptsOpioid agonist therapyXR-NTXExtended-release naltrexonePsychological supportOpioid use disorderHIV prevention effortsFocus groupsPerceptions of recoveryAgonist therapyOpioid withdrawalYoung PWIDOpioid antagonistPatient preferencesNew pharmacotherapiesPsychoactive medicationsInjection careerUse disordersFocus group transcriptsPWIDPrevention effortsNaltrexoneGroup transcriptsIndividual barriersTreatmentWithdrawal
2017
Patient preferences and extended-release naltrexone: A new opportunity to treat opioid use disorders in Ukraine
Marcus R, Makarenko I, Mazhnaya A, Zelenev A, Polonsky M, Madden L, Filippovych S, Dvoriak S, Springer SA, Altice FL. Patient preferences and extended-release naltrexone: A new opportunity to treat opioid use disorders in Ukraine. Drug And Alcohol Dependence 2017, 179: 213-219. PMID: 28806638, PMCID: PMC5599372, DOI: 10.1016/j.drugalcdep.2017.07.010.Peer-Reviewed Original ResearchMeSH KeywordsHumansInjectionsNaltrexoneNarcotic AntagonistsOpioid-Related DisordersPatient PreferenceUkraineConceptsOpioid agonist therapyOpioid use disorderExtended-release naltrexoneXR-NTXHIV preventionIndependent correlatesPatient preferencesUse disordersShort-term injectorsPatient-centered treatmentAgonist therapyPharmacological therapyHIV incidenceTreatment optionsPWIDTreatment entryAddiction treatmentPreventionNaltrexoneShort durationTherapyNegative attitudesDisordersNew optionsTreatmentExtended-release naltrexone reduces alcohol consumption among released prisoners with HIV disease as they transition to the community
Springer SA, Di Paola A, Azar MM, Barbour R, Krishnan A, Altice FL. Extended-release naltrexone reduces alcohol consumption among released prisoners with HIV disease as they transition to the community. Drug And Alcohol Dependence 2017, 174: 158-170. PMID: 28334661, PMCID: PMC5407009, DOI: 10.1016/j.drugalcdep.2017.01.026.Peer-Reviewed Original ResearchConceptsHeavy drinking daysAlcohol use disorderFirst heavy drinking dayExtended-release naltrexoneXR-NTXDrinking daysPlacebo groupAlcohol consumptionDrinks/drinking dayPlacebo-controlled trialSerious adverse eventsDrinks/daySignificant differencesMonthly injectionsAdverse eventsHIV diseaseHIV outcomesTreatment armsAlcohol scoresMAIN OUTCOMEAlcohol consumption scoresUse disordersImprovement scoresDrinking outcomesNaltrexone
2015
Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system
Springer SA, Brown SE, Di Paola A, Altice FL. Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system. Drug And Alcohol Dependence 2015, 157: 158-165. PMID: 26560326, PMCID: PMC4675147, DOI: 10.1016/j.drugalcdep.2015.10.023.Peer-Reviewed Original ResearchConceptsAlcohol use disorderExtended-release naltrexoneOpioid use disorderXR-NTXUse disordersHIV diseaseFirst injectionDouble-blind placebo-controlled randomized trialSecond injectionPlacebo-controlled randomized trialSubstance use disordersMultivariate regression analysisTreatment of alcoholCorrelates of retentionAntiretroviral therapyStudy drugHIV infectionRandomized trialsUrine testsUrine screensEligible personsDays of releaseHazardous drinkingCocaine useDemographic featuresMen Who Have Sex With Men in Peru: Acceptability of Medication-Assisted Therapy for Treating Alcohol Use Disorders
Brown SE, Vagenas P, Konda KA, Clark JL, Lama JR, Gonzales P, Sanchez J, Duerr AC, Altice FL. Men Who Have Sex With Men in Peru: Acceptability of Medication-Assisted Therapy for Treating Alcohol Use Disorders. American Journal Of Men's Health 2015, 11: 1269-1278. PMID: 25787988, PMCID: PMC4573823, DOI: 10.1177/1557988315576775.Peer-Reviewed Original ResearchConceptsMSM/transgender womenAlcohol use disorderMedication-assisted therapyTransgender womenUse disordersManagement of AUDAntiretroviral therapy adherenceAlcohol problemsRisky sexual behaviorPeruvian MSMTherapy adherenceClinical trialsHIV epidemicTreatment programTotal abstinenceLess alcoholTherapyThematic content analysisMultiple studiesMedicationsSexual behaviorHIVDrinking behaviorMenFamily support
2014
Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community
Di Paola A, Lincoln T, Skiest DJ, Desabrais M, Altice FL, Springer SA. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community. Contemporary Clinical Trials 2014, 39: 256-268. PMID: 25240704, PMCID: PMC4283549, DOI: 10.1016/j.cct.2014.09.002.Peer-Reviewed Original ResearchConceptsOpioid agonist treatmentPlacebo-controlled trialXR-NTXAgonist treatmentOpioid dependenceTreatment outcomesPoor HIV treatment outcomesOpioid treatment outcomesOpioid-dependent prisonersExtended-release naltrexoneHIV treatment outcomesHIV transmission riskEvidence-based treatmentsCriminal justice settingsEarly acceptabilityStudy medicationFirst injectionStudy acceptabilityHIVTotal referralsJail detaineesCommunity settingsTransmission riskDrug relapseHigh internal validityAn evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone
Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone. Journal Of Substance Use And Addiction Treatment 2014, 47: 35-40. PMID: 24674234, PMCID: PMC4042403, DOI: 10.1016/j.jsat.2014.02.008.Peer-Reviewed Original ResearchConceptsPlacebo-controlled trialXR-NTXGamma-glutamyl transferaseAlanine aminotransferaseMental illnessAspartate aminotransferaseRandomized placebo-controlled trialMonthly injectable formulationXR-NTX armExtended-release naltrexoneHepatic enzyme elevationHepatic enzyme levelsRelease naltrexoneAntiretroviral therapyHCV infectionBaseline characteristicsHepatic transaminasesEnzyme elevationPsychiatric medicationsHepatotoxicity concernsGlutamyl transferaseAlcohol dependenceOpioidsHIVNaltrexone
2013
Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community
Springer SA, Altice FL, Herme M, Di Paola A. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community. Contemporary Clinical Trials 2013, 37: 209-218. PMID: 24384538, PMCID: PMC3992862, DOI: 10.1016/j.cct.2013.12.006.Peer-Reviewed Original ResearchConceptsPlacebo-controlled trialHIV treatment outcomesTreatment outcomesCriminal justice system (CJS) populationsPoor antiretroviral therapy (ART) adherenceAlcohol useExtended-release naltrexoneAntiretroviral therapy adherenceMedication-assisted therapyPrevention of relapseAlcohol use disorderSexual risk-taking behaviorsAlcohol-dependent personsXR-NTXHigh morbidityTherapy adherenceAlcohol relapseHigh prevalenceStudy participationEligibility criteriaUse disordersHIVRelapseHazardous drinkingNaltrexone