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Combined Treatment for Alcohol-Dependent Individuals With PTSD

NCT00262223 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-03-03

Study results available
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Summary

This treatment intervention trial is designed for men and women with either alcohol misuse (e.g. hazardous or binge drinking) or alcohol use disorders (alcohol abuse or dependence) and comorbid PTSD. Participants will be randomly assigned to one of two treatments (a cognitive behavioral treatment intervention called "Seeking Safety" + Medication ("Zoloft") or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-treatment.

Conditions

  • Stress Disorders, Post-Traumatic
  • Alcohol Abuse
  • Substance-Related Disorders

Interventions

BEHAVIORAL

Seeking Safety

Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders

DRUG

Sertraline

An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type

DRUG

Pill placebo

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Denise A. Hien, PhD · City College of New York & New York State Psychiatric Institute/Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00262223 on ClinicalTrials.gov