title: Safety, tolerability, and feasibility of high-dose naltrexone in alcohol dependence: an open-label study.
abstract: OBJECTIVE
  Prior trials testing standard-dose naltrexone (50 mg/day) have generated mixed results in the treatment of alcohol dependence. The purpose of this study was to evaluate the short-term safety, tolerability, and feasibility of high-dose naltrexone (150 mg/day) for treating alcohol-dependent patients with prominent alcohol craving.
  
  
  METHODS
  Twenty-four alcohol-dependent outpatients received high-dose naltrexone at a dose of 150 mg/day in an 8-week open-label pilot study. All patients had current alcohol dependence and alcohol craving symptoms. Safety and tolerability were assessed weekly. Liver function tests were obtained at weeks 0, 3, 5, 7, and 9. The main outcome measures were percentage of drinking days and number of drinks per drinking day.
  
  
  RESULTS
  High-dose naltrexone was safe and well tolerated using the procedure described. No serious adverse effects were reported. The mean of γ-glutamyl transferase showed an improvement trend (p = 0.06), and other hepatic transaminase profiles were stable during the trial. High-dose naltrexone significantly reduced alcohol consumption (percentage of drinking days (p < 0.0001); and number of drinks per drinking day (p < 0.0001)).
  
  
  CONCLUSIONS
  High-dose naltrexone may serve as a viable treatment option for alcohol-dependent patients with prominent alcohol craving. Further controlled studies are needed to confirm our findings.
authors: Minneapolis VA Medical Center, Minneapolis, Minnesota 55417, USA. yoonx033@umn.edu
authors: Gihyun
authors: G
authors: Yoon
authors: Suck Won
authors: SW
authors: Kim
authors: Paul
authors: P
authors: Thuras
authors: Joseph
authors: J
authors: Westermeyer
mesh_terms: D000328:Adult; D000437:Alcoholism / Q000188:drug therapy* / Q000523:psychology; D004244:Dizziness / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage* / Q000009:adverse effects*; D009325:Nausea / Q000139:chemically induced; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D009271:Naltrexone