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
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 validity