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Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

This study has been completed.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2004

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 2

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

Resource links provided by NLM:

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

Estimated Study Completion Date: December 2000

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00000446

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 Identifier: NCT00000446     History of Changes
Other Study ID Numbers: NIAAABRA10761
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Pathologic Processes
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs processed this record on September 19, 2017