Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00000446

Purpose

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.

Condition	Intervention	Phase
Alcoholism Post-Traumatic Stress Disorder	Drug: sertraline (Zoloft)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Post-Traumatic Stress Disorder

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Study Completion Date:

December 2000

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000446

Locations

United States, South Carolina
Department of Psychiatry and Behavioral Science, Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000446 History of Changes
Other Study ID Numbers:	NIAAABRA10761
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Anxiety Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012