Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial.

All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Post-traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry and Behavioral Science, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder.
Laboratory tests for blood and urinalysis must be within normal limits.
Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions.
Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal.

Exclusion criteria

Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days.
Currently suicidal.
Medical reasons not to receive drug therapy.
Allergy or hypersensitivity to selective serotonin inhibitor antidepressants.
Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.
Liver function test greater than 2 times the normal level
Require ongoing therapy with another psychoactive drug during the study period.
Females who are pregnant or lactating.

Treatment and study plan

sertraline (Zoloft)

Drug

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Registry information

Official study title

Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism

Important dates

Study completion: 2000
First posted: Nov 3, 1999
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed