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Improving Clinical Outcomes in Treating Heroine Dependence :Randomised Controlled Trial of Oral or Implant Naltrexone

Hulse, Gary; Morris, Noella; Arnold-Reed, Diane; Tait, Robert

Description

Context: Oral naltrexone hydrochloride effectively antagonizes heroin, but its utility is limited by patient noncompliance. Sustained-release preparations may overcome this limitation. Objective: To compare the safety and efficacy of a single-treatment sustained-release naltrexone implant with daily oral naltrexone treatment. Design: Seventy heroin-dependent volunteers entered a randomized, double-blind, double-placebo controlled trial with a 6-month follow-up period. Patients: Eligibility...[Show more]

dc.contributor.authorHulse, Gary
dc.contributor.authorMorris, Noella
dc.contributor.authorArnold-Reed, Diane
dc.contributor.authorTait, Robert
dc.date.accessioned2015-12-10T21:57:26Z
dc.date.available2015-12-10T21:57:26Z
dc.identifier.issn0003-990X
dc.identifier.urihttp://hdl.handle.net/1885/39774
dc.description.abstractContext: Oral naltrexone hydrochloride effectively antagonizes heroin, but its utility is limited by patient noncompliance. Sustained-release preparations may overcome this limitation. Objective: To compare the safety and efficacy of a single-treatment sustained-release naltrexone implant with daily oral naltrexone treatment. Design: Seventy heroin-dependent volunteers entered a randomized, double-blind, double-placebo controlled trial with a 6-month follow-up period. Patients: Eligibility criteria were DSM-IV opioid (heroin) dependence; age 18 years or older; willingness to be randomized; residing in the Perth, Western Australia, metropolitan area; and completion of preclinical screening and written consent. A total of 129 eligible participants were identified, and 70 (54%) provided informed consent and were randomized as per the study design. Intervention: Participants received oral naltrexone, 50 mg/d, for 6 months (plus placebo implants) or a single dose of 2.3 g of naltrexone implant (plus placebo tablets). Main Outcome Measures: (1) Maintaining therapeutic naltrexone levels above 2 ng/mL; (2) return to regular heroin use (≥4 d/wk); (3) other heroin use and abstinence; (4) use of illicit nonopioid drugs; (5) number of opiate overdoses requiring hospitalization; (6) treatment-related unexpected and expected adverse events; and (7) blood naltrexone levels (ie, pharmacokinetic profile) for recipients of active naltrexone implants. Results: More participants in the oral vs the implant group had blood naltrexone levels below 2 ng/mL in months 1 (P<.001) and 2 (P=.01); in addition, more oral group participants had returned to regular heroin use by 6 months (P=.003) and at an earlier stage (median [SE], 115 [12.0] days vs 158 [9.4] days). There were 10 trial-related, unexpected adverse events. One serious adverse event, a wound hematoma, was associated with surgical implantation. Naltrexone blood levels in implant recipients were maintained above 1 and 2 ng/mL for 101 (95% confidence interval, 83-119) and 56 (39-73) days, respectively, among men and 124 (88-175) and 43 (16-79) days among women. Conclusions: The naltrexone implant effectively reduced relapse to regular heroin use compared with oral naltrexone and was not associated with major adverse events. Clinical Trial Registration: anzctr.org.au Identifier: ACTRN12606000308594.
dc.publisherAmerican Medical Association
dc.sourceArchives of General Psychiatry
dc.subjectKeywords: naltrexone; placebo; adult; article; clinical trial; controlled clinical trial; controlled study; diagnostic and statistical manual of mental disorders; diarrhea; double blind procedure; drug blood level; drug efficacy; drug safety; female; hematoma; hero
dc.titleImproving Clinical Outcomes in Treating Heroine Dependence :Randomised Controlled Trial of Oral or Implant Naltrexone
dc.typeJournal article
local.description.notesImported from ARIES
local.identifier.citationvolume66
dc.date.issued2009
local.identifier.absfor120101 - Architectural Design
local.identifier.ariespublicationU4146231xPUB183
local.type.statusPublished Version
local.contributor.affiliationHulse, Gary, University of Western Australia
local.contributor.affiliationMorris, Noella, University of Western Australia
local.contributor.affiliationArnold-Reed, Diane, University of Notre Dame
local.contributor.affiliationTait, Robert, College of Medicine, Biology and Environment, ANU
local.bibliographicCitation.issue10
local.bibliographicCitation.startpage1108
local.bibliographicCitation.lastpage1115
local.identifier.doi10.1001/archgenpsychiatry.2009.130
dc.date.updated2016-02-24T10:37:26Z
local.identifier.scopusID2-s2.0-70349667302
CollectionsANU Research Publications

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