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Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000446
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE November 3, 1999
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Official Title  ICMJE Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
Brief Summary

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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Alcoholism
  • Post-Traumatic Stress Disorder
Intervention  ICMJE Drug: sertraline (Zoloft)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE December 2000
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000446
Other Study ID Numbers  ICMJE NIAAABRA10761
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP