Official Title: “Sertraline for Alcohol Dependence and Depression”

This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 16 weeks. The followup phase includes two visits at 6 and 9 months after treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: naltrexone (Revia)
• Drug: sertraline (Zoloft)

Inclusion Criteria:

• Current diagnosis of major depression for a 2-week duration following discontinuation of drinking or prior to study.
• Meets criteria for alcohol dependence.
• Drank a minimum of 48 standard alcoholic drinks prior to treatment (average of 12 drinks/week) on 40% of the 30 days before treatment.
• Able to maintain abstinence for four days with or without the aid of detoxification medications.
• Lives within 50 miles of the study site.
• Speaks, understands and prints in English.

Exclusion Criteria:

• Ever abused or dependent on opiates or evidence of opiate use in month prior to treatment.
• Meets criteria for dependence on any substance other than alcohol (except nicotine).
• Tests positive on the urine drug screen at the initial visit.
• Meets criteria for panic, obsessive-compulsive, post-traumatic stress, or eating disorders.
• Meets current or lifetime criteria for bipolar affective disorder, schizophrenia or any psychiatric disorder, or organic mental disorder.
• Has evidence of or a history of significant hematological, pulmonary, endocrine, cardiovascular, renal, or gastrointestinal disease.
• Hepatocellular disease.
• Abnormal elevation in bilirubin.
• Needs treatment with any psychoactive medication including antiseizure medications.
• Current use of disulfiram.
• Has taken a monoamine oxidase inhibitors, serotonin reuptake inhibitor or opiate antagonist in the month prior to randomization.
• Is or has been taking an investigational drug within one month prior to study.
• Females who are pregnant, contemplating pregnancy in the next six months, nursing or not using an effective contraceptive birth control method (if relevant).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004554

Study ID Number: NIAAAPET09544

ClinicalTrials.gov Identifier: NCT00004554

Health Authority: United States: Federal Government