Sertraline and Cognitive Therapy in Depressed Alcoholics

• Status: Completed
• Trial end date: 2002-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.