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 medications
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 levelsOutcomes
2017
Corrigendum to “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” [Contemp. Clin. Trials (2014) 209–218]
Springer SA, Altice FL, Herme M, Di Paola A. Corrigendum to “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” [Contemp. Clin. Trials (2014) 209–218]. Contemporary Clinical Trials 2017, 57: 98. PMID: 28341227, DOI: 10.1016/j.cct.2017.03.008.Peer-Reviewed Original ResearchCorrigendum to ‘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 Abuse Treatment 47 (2014) 35–40]
Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. Corrigendum to ‘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 Abuse Treatment 47 (2014) 35–40]. Journal Of Substance Use And Addiction Treatment 2017, 77: 44. PMID: 28476270, PMCID: PMC5458355, DOI: 10.1016/j.jsat.2017.03.008.Peer-Reviewed Original ResearchExtended-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
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