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Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)

NCT00006489 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2017-04-21

Study results available
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Summary

This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.

Conditions

  • Alcoholism
  • Alcohol Dependence
  • Post-Traumatic Stress Disorder

Interventions

BEHAVIORAL

Cognitive-Behavioral Therapy

Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week

DRUG

Naltrexone

Daily dosing 100 mg for 24 weeks

DRUG

Placebo

Pill Placebo daily dosing 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Edna B. Foa, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2000-12-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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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 NCT00006489 on ClinicalTrials.gov