NCT00000446

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2004

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

AlcoholismPost-Traumatic Stress Disorder

Interventions

sertraline (Zoloft)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

AlcoholismStress Disorders, Post-Traumatic

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

December 1, 2000

Last Updated

June 24, 2005

Record last verified: 2004-04

Locations

US(1)