Naltrexone and disulfiram in patients with alcohol dependence and comorbid psychiatric disorders
Abstract
Background Disulfiram and naltrexone are approved by the Food and Drug Administration (FDA) for the treatment of alcoholism, but these agents have not been rigorously evaluated in dually diagnosed individuals.Method Two-hundred and fifty-four patients with an Axis I psychiatric disorder and comorbid alcohol dependence were treated for 12 weeks in an outpatient medication study conducted at three Veterans Administration outpatient clinics. Randomization included assignment to one of four groups: 1) naltrexone alone; 2) placebo alone; 3) (open-label) disulfiram and (blinded) naltrexone; or 4) (open-label) disulfiram and (blinded) placebo. Medication compliance was evaluated using the Microelectric Events Monitoring System. Primary outcomes were measures of alcohol use. Secondary outcomes included psychiatric symptoms, alcohol craving, g-GGT levels and adverse events.Results There was a high rate of abstinence across groups. Subjects treated with an active medication had significantly more consecutive weeks of abstinence and less craving than those treated with placebo, but there were no significant group differences in other measures of alcohol consumption. There was no advantage of the combination of both medications.Conclusions These data suggest a modest advantage for the use of disulfiram and naltrexone for this group of dually diagnosed alcohol-dependent individuals but did not suggest an advantage in the combination.
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In combined control groups, six participants reported serious adverse events requiring hospitalization from three studies.
“In the combined control groups, six participants reported serious adverse events requiring hospitalization from three studies [38], [39], [42].”
From Disulfiram Efficacy in the Treatment of Alcohol Dependence: A Meta-Analysis (2014) · cites this paper as [38]
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- Authors
- Petrakis, I. L., Poling, J., Levinson, C., Nich, C., Carroll, K., & Rounsaville, B.
- Affiliations
- Yale University (US)
- Corresponding author
- Petrakis, Ismene L.
- Venue
- Biological Psychiatry
- Publisher
- Elsevier BV
- Published
- 2005-05
- Volume
- 57
- Issue
- 10
- Pages
- 1128-1137
- ISSN
- 0006-3223 (ISSN-L)
- OpenAlex
- W1985702729
- Cited by
- 177
- References
- 42
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 4 · 2023: 1 · 2022: 4 · 2021: 3 · 2020: 11 · 2019: 7 · 2018: 6 · 2017: 8 · 2016: 10 · 2015: 6 · 2014: 14 · 2013: 12 · 2012: 13
- FWCI
- 9.03
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biological Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Drug Abuse (K05DA000457)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Health Sciences › Medicine › Neurology › Alcoholism and Thiamine Deficiency
- Keywords
- naltrexone, disulfiram, alcoholism, psychiatric comorbidity, veterans, alcohol craving, alcohol abstinence, combination pharmacotherapy, gamma-glutamyl transferase, medication adherence
- MeSH terms
- Alcohol Deterrents, Alcoholism, Mental Disorders, Disulfiram, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Naltrexone, Narcotic Antagonists, Psychiatric Status Rating Scales, Treatment Outcome, Diagnosis, Dual (Psychiatry)
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