Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Completion Date

2000-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcoholism Post-Traumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sertraline (Zoloft)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Charleston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIAAABRA10761

Identifier Type: -

Identifier Source: org_study_id