title: Naltrexone and disulfiram in patients with alcohol dependence and current depression.
abstract: OBJECTIVE
  Although disulfiram and naltrexone have been approved by the Food and Drug Administration for the treatment of alcoholism, no medications have been approved for individuals with alcohol dependence and comorbid psychiatric disorders. In particular, the effect of these medications on alcohol use outcomes and on specific psychiatric symptoms is still unknown in patients with the most common co-occurring disorder, major depression.
  
  
  METHODS
  Two hundred fifty-four patients with a major Axis I psychiatric disorder and comorbid alcohol dependence were treated for 12 weeks in an outpatient medication study conducted at 3 Veterans Administration outpatient clinics. Randomization included (1) open randomization to disulfiram or no disulfiram, and (2) double-blind randomization to naltrexone or placebo. This resulted in 4 groups: (1) naltrexone alone, (2) placebo alone, (3) disulfiram and naltrexone, and (4) disulfiram and placebo. Primary outcomes were measures of alcohol use. Secondary outcomes included psychiatric symptoms assessed by the Hamilton Depression Rating Scale, alcohol craving, gamma-glutamyltransferase levels, and adverse events.
  
  
  RESULTS
  One hundred thirty-nine subjects (54.7%) met the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for major depression. There was no relationship between the diagnosis of depression and medication treatment on alcohol use outcomes, psychiatric symptoms, or the reporting of side effects for these medications. There was a significant interaction between diagnosis, medication group, and craving, where subjects with depression on disulfram reported lower craving over time than subjects with depression on naltrexone.
  
  
  CONCLUSIONS
  The results suggest that disulfiram and naltrexone are safe pharmacotherapeutic agents for dually diagnosed individuals with depression for the treatment of alcohol use disorders.
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, Veterans Affairs Connecticut Healthcare System, West Haven Campus, West Haven, CT 06516, USA. ismene.petrakis@yale.edu
authors.forename: Ismene
authors.initials: I
authors.lastname: Petrakis
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ralevski
authors.forename: Charla
authors.initials: C
authors.lastname: Nich
authors.forename: Carolyn
authors.initials: C
authors.lastname: Levinson
authors.forename: Kathleen
authors.initials: K
authors.lastname: Carroll
authors.forename: James
authors.initials: J
authors.lastname: Poling
authors.forename: Bruce
authors.initials: B
authors.lastname: Rounsaville
mesh_terms: D000427:Alcohol Deterrents / Q000009:adverse effects / Q000627:therapeutic use; D000437:Alcoholism / Q000188:drug therapy* / Q000453:epidemiology; D001714:Bipolar Disorder / Q000188:drug therapy / Q000453:epidemiology; D019970:Cocaine-Related Disorders / Q000188:drug therapy / Q000453:epidemiology; D015897:Comorbidity; D003237:Connecticut / Q000453:epidemiology; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology; D004221:Disulfiram / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008404:Massachusetts / Q000453:epidemiology; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000188:drug therapy / Q000453:epidemiology; D012559:Schizophrenia / Q000188:drug therapy / Q000453:epidemiology; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy / Q000453:epidemiology; D016896:Treatment Outcome; D014728:Veterans; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D000427:Alcohol Deterrents; D009292:Narcotic Antagonists; D009271:Naltrexone; D005723:gamma-Glutamyltransferase; D004221:Disulfiram