TY  - JOUR
T1  - Improving clinical outcomes in treating heroin dependence: Randomized, controlled trial of oral or implant naltrexone
AU  - Hulse GK, Morris N, Arnold-Reed D, Tait RJ
Y1  - 2009/10/01
N1  - 10.1001/archgenpsychiatry.2009.130
JO  - Archives of General Psychiatry
SP  - 1108
EP  - 1115
VL  - 66
IS  - 10
N2  - 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 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
SN  - 0003-990X
M3  - doi: 10.1001/archgenpsychiatry.2009.130
UR  - http://dx.doi.org/10.1001/archgenpsychiatry.2009.130
ER  -