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Sertraline for Alcohol Dependence and Depression

This study has been completed.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00004554
  Purpose

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.


Condition Intervention Phase
Alcoholism
Depression
Drug: naltrexone (Revia)
Drug: sertraline (Zoloft)
Phase IV

MedlinePlus related topics:   Alcoholism    Depression   

ChemIDplus related topics:   Sertraline hydrochloride    Sertraline    Naltrexone    Naltrexone hydrochloride    Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:   Sertraline for Alcohol Dependence and Depression

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment:   160
Estimated Study Completion Date:   April 2004

  Eligibility
Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004554

Locations
United States, Pennsylvania
Treatment Research Center, University of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators
  More Information


Study ID Numbers:   NIAAAPET09544
First Received:   February 4, 2000
Last Updated:   December 18, 2007
ClinicalTrials.gov Identifier:   NCT00004554
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Depression
Disorders of Environmental Origin
Depressive Disorder
Serotonin
Behavioral Symptoms
Mental Disorders
Alcoholism
Naltrexone
Substance-Related Disorders
Mood Disorders
Sertraline
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on October 10, 2008




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