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Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Alcoholism
Post-Traumatic Stress Disorder

Treatments

Drug: sertraline (Zoloft)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000446
NIAAABRA10761

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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