title: [Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomized trial].
abstract: We aimed to assess the efficacy and safety of an injectable, once monthly extended-release formulation of the opioid antagonist naltrexone (XR-NTX) for treatment of patients with opioid dependence after detoxification. Two hundreds and fifty patients with opioid dependence were enrolled into the double-blind, placebo-controlled, randomized, 24-week trial. Patients aged 18 years or over who had inpatient detoxification and 7 days or more off all opioids were enrolled at 13 clinical sites in Russia. We randomly assigned patients (1:1) to either 380 mg XR-NTX (n=124) or placebo (n=126). Participants also received 12 biweekly counseling sessions. The primary endpoint was the response profile for confirmed abstinence during weeks 5-24 assessed by urine drug tests and self report of non-use. Secondary endpoints were self-reported opioid- free days, opioid craving scores, number of days of retention, and relapse to physiological opioid dependence.
  
  
  CONCLUSIONS
  XR-NTX represents a new treatment option. XR-NTX in conjunction with psychosocial treatment was more effective for treatment of opioid dependence compare to psychosocial support and placebo.
authors.forename: E M
authors.initials: EM
authors.lastname: Krupitskiĭ
authors.forename: E V
authors.initials: EV
authors.lastname: Nunes
authors.forename: W
authors.initials: W
authors.lastname: Ling
authors.forename: A
authors.initials: A
authors.lastname: Illeperuma
authors.forename: D R
authors.initials: DR
authors.lastname: Gastfriend
authors.forename: E A
authors.initials: EA
authors.lastname: Blokhina
authors.forename: B L
authors.initials: BL
authors.lastname: Silverman
mesh_terms: D000328:Adult; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage* / Q000009:adverse effects; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone