Sertraline and Cognitive Therapy in Depressed Alcoholics

NCT00000458 | Completed Phase 2

• 1 other identifier: NIAAAMOA10476
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess whether individuals treated with sertraline (Zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment.

Conditions

Alcoholism; Depression

Interventions

sertraline (Zoloft) DRUG

cognitive behavior therapy BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets criteria for major depressive episode.
• Meets criteria for alcohol abuse or dependence thirty days prior to entering the study.
• Has had no more than one previous inpatient medical detoxification.
• Able to maintain sobriety for ten days.
• Able to read and understand questionnaires and informed consent.
• Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting.

You may not qualify if:

• Meets criteria for any other psychoactive substance dependence other than nicotine.
• Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study.
• Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder.
• Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication.
• Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study.
• Current use of disulfiram (Antabuse) or anti-seizure medications.
• Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion.
• Hepatocellular disease.
• Females who are pregnant, nursing, or not using a reliable form of birth control.
• Current charges pending for violent crime (excluding DUI related offenses).
• Previous adverse experience with a serotonin reuptake inhibitor.
• Current homicidal or suicidal ideation.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism; Depression

Interventions

Sertraline; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Completion: January 1, 2002
• Last Updated: June 24, 2005

Record last verified: 2002-08

Locations

US (1)