We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00004554
Previous Study | Return to List | Next Study

Sertraline for Alcohol Dependence and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004554
Recruitment Status : Completed
First Posted : February 7, 2000
Last Update Posted : October 6, 2015
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.

Condition or disease Intervention/treatment Phase
Alcoholism Depression Drug: naltrexone (Revia) Drug: sertraline (Zoloft) Drug: Placebo Phase 4

Detailed Description:
The proposed study will examine managing relapse in patients with alcohol dependence and depression using a 14-week double-blind, placebo-controlled, combination of 100 mg/day of naltrexone, 200 mg/day of sertraline, and individual, cognitive behavioral therapy (CBT). For testing the medication, the design will be 2x2, consisting of four groups: naltrexone/sertraline, naltrexone only, sertraline only, placebo. All four groups will receive once weekly sessions of CBT given by therapists experienced in working with patients with substance disorders and trained in the principles of CBT.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sertraline for Alcohol Dependence and Depression
Study Start Date : January 2000
Actual Primary Completion Date : August 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sertraline
Drug: sertraline (Zoloft)

Experimental: Naltrexone
Drug: naltrexone (Revia)

Experimental: Nal/Sert
Drug: naltrexone (Revia)

Drug: sertraline (Zoloft)

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female outpatients 18 75 years of age.
  • Patients must have met DSM-IV criteria for (primary or substance-induced) major depressive episode prior to randomization.
  • Patients must have a current DSM-IV diagnosis of alcohol dependence.
  • Patients must have a total score of 10 or higher on the Hamilton Depression Scaleat the day of randomization. Also, item 1 on the scale must be > 1.
  • Patients must have drank sufficient alcohol in the month prior to coming for treatment so that a practical assessment in reductions in drinking during and after treatment can be performed. The guidelines we will follow for this study as to what we think is sufficient will be that the patient in the month prior to coming to treatment will have drank on 40% or more of the days or drank more than 40 standard drinks (an average of 10 drinks per week).
  • Patients must have successfully completed medical detoxification for alcohol (are abstinent for 4 consecutive days) or if medical detoxification is not indicated, have been abstinent for 4 consecutive days since coming to treatment but before initiating the study medication/placebo.
  • Females of childbearing potential must have a negative pregnancy test and not contemplating pregnancy within the next 6 months. They must also use a contraceptive method judged by the investigator to be effective.

Exclusion Criteria:

  • Patients with evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screens (only one repeat testing permitted). Patients with a history of treatment for opiate dependence will be excluded.
  • Patients who, within the past year, met DSM IV criteria for dependence on any psychoactive substance other than alcohol or nicotine. Patients who test positive on the urine drug screen (with the exception of THC) at the initial visit (only one repeat testing permitted).
  • Patients who meet DSM-IV criteria for past history or current disorder of schizophrenia or any psychotic disorder, or bipolar disorder.
  • Patients with evidence or history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease. (If there is a history of such disease but the condition has been stable for more than one year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.)
  • Patients with abnormal liver function tests (AST or ALT) (more than 3.5 times the upper level of the normal value) or patients with any abnormal elevation in bilirubin.
  • Patients requiring concomitant therapy with any psychotropic drug (with the exception of benadryl used sparingly if necessary for sleep or oxeazepam for detoxification or nicotine replacement therapy).
  • Patients who have taken fluoxetine (Prozac) during the 6 weeks prior to randomization --due to its long half-life.
  • Patients who have taken monoamine oxidase inhibitors (MAOI) during the 2 weeks prior to randomization -- due to the potential toxicity of combining MAOI medications with serotonin-specific ones. (Patients will also be instructed not to take MAOI for 2 weeks after completing the study.)
  • Past use of antidepressants or other psychotropic medications (except as specified above) within 7 days of randomization.
  • Patients on concomitant therapy with an investigational drug, or patients who have been in an investigational drug study within one month prior to entering this study.
  • Patients who are unable to read or print in English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004554

Layout table for location information
United States, Pennsylvania
Treatment Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Layout table for investigator information
Principal Investigator: Helen Pettinati, PhD University of Pennsylvania
Publications of Results:
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00004554    
Other Study ID Numbers: NIAAAPET09544
First Posted: February 7, 2000    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: September 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents