title: [Injectable extended-release naltrexone for opioid dependence: an open label study of long-term safety and efficacy].
abstract: OBJECTIVE
  To evaluate efficacy and safety of injectable extended-release naltrexone (XR-NTX, Vivitrol), an opioid receptor antagonist, in the treatment of opioid dependence, we carried out a 1-year open-label extension study.
  
  
  METHODS
  The study followed the initial 6-month randomized, double-blind, PBO-controlled investigation of XR-NTX, used in dose 380 mg, as a treatment for opioid dependence. The study was conducted at 13 clinical sites in Russia. The main measurements were monthly urine samples (efficacy) and adverse events (safety).
  
  
  CONCLUSIONS
  The open-label extension included 114 patients (67 continued on XR-NTX and 47 switched from placebo). Overall, 62.3% (95% CI: 52.7%, 71.2%) of patients completed the extension. Urine testing revealed that 50.9% (41.5%, 60.4%) were abstinent from opioids at all assessments during the 1-year open-label phase. Adverse events were reported by 21.1% of patients. Elevations in liver function tests occurred in 16.7% of patients. No severe adverse events were reported. The data obtained demonstrate the long-term safety and efficacy of XR-NTX in opioid dependent patients.
authors.forename: E M
authors.initials: EM
authors.lastname: Krupitsky
authors.forename: E V
authors.initials: EV
authors.lastname: Nunes
authors.forename: W
authors.initials: W
authors.lastname: Ling
authors.forename: D R
authors.initials: DR
authors.lastname: Gastfriend
authors.forename: A
authors.initials: A
authors.lastname: Memisoglu
authors.forename: E A
authors.initials: EA
authors.lastname: Blokhina
authors.forename: B L
authors.initials: BL
authors.lastname: Silverman
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D009292:Narcotic Antagonists; D009271:Naltrexone