Randomized Trial of Long-Acting Sustained-Release Naltrexone Implant vs Oral Naltrexone or Placebo for Preventing Relapse to Opioid Dependence

CONTEXT Sustained-release naltrexone implants may improve outcomes of nonagonist treatment of opioid addiction. OBJECTIVE To compare outcomes of naltrexone implants, oral naltrexone hydrochloride, and nonmedication treatment. DESIGN Six-month double-blind, double-dummy, randomized trial. SETTING Add...

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Veröffentlicht in:Archives of general psychiatry 2012-09, Vol.69 (9), p.973-981
Hauptverfasser: Krupitsky, Evgeny, Zvartau, Edwin, Blokhina, Elena, Verbitskaya, Elena, Wahlgren, Valentina, Tsoy-Podosenin, Marina, Bushara, Natalia, Burakov, Andrey, Masalov, Dmitry, Romanova, Tatyana, Tyurina, Arina, Palatkin, Vladimir, Slavina, Tatyana, Pecoraro, Anna, Woody, George E
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Sprache:eng
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Zusammenfassung:CONTEXT Sustained-release naltrexone implants may improve outcomes of nonagonist treatment of opioid addiction. OBJECTIVE To compare outcomes of naltrexone implants, oral naltrexone hydrochloride, and nonmedication treatment. DESIGN Six-month double-blind, double-dummy, randomized trial. SETTING Addiction treatment programs in St Petersburg, Russia. PARTICIPANTS Three hundred six opioid-addicted patients recently undergoing detoxification. INTERVENTIONS Biweekly counseling and 1 of the following 3 treatments for 24 weeks: (1) 1000-mg naltrexone implant and oral placebo (NI+OP group; 102 patients); (2) placebo implant and 50-mg oral naltrexone hydrochloride (PI+ON group; 102 patients); or (3) placebo implant and oral placebo (PI+OP group; 102 patients). MAIN OUTCOME MEASURE Percentage of patients retained in treatment without relapse. RESULTS By month 6, 54 of 102 patients in the NI+OP group (52.9%) remained in treatment without relapse compared with 16 of 102 patients in the PI+ON group (15.7%) (survival analysis, log-rank test, P 
ISSN:0003-990X
1538-3636
DOI:10.1001/archgenpsychiatry.2012.1a