Post Traumatic Stress Disorder/ptsd |
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Clinical Trial: Treatment for Alcoholism and Post-Traumatic Stress Disorder (naltrexone)
This study is currently recruiting patients.
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Purpose
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. Followup assessments will be completed at 9 and 12 months after treatment.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism Post-Traumatic Stress Disorder | Drug: naltrexone (Revia) Behavior: prolonged exposure | Phase IV |
MedlinePlus related topics: Alcoholism; Post-Traumatic Stress Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title: Naltrexone and Cognitive-Behavioral Therapy for Patients with Alcoholism and Post-Traumatic Stress Disorder
Expected Total Enrollment: 200
Expected completion: August 2005
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Meets criteria for alcohol dependence and post-traumatic stress disorder.
- Heavy drinking in the past 30 days (an average of more than 12 alcohol drinks per week with at least 1 day of 4 or more drinks).
- Successfully complete medical detoxification.
- Exhibit clinically significant trauma-related symptoms.
- Live in a commutable distance to the University of Pennsylvania and agree to followup visits.
- Able to provide an informed consent.
- Speak and read English.
Exclusion Criteria:
- Current diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
- Evidence of opiate use in the past 30 days.
- Significant risk of violence or history of serious violent behavior during the past year.
- Receiving current treatment with any psychotropic medication (excluding short-term use of benzodiazepines for detoxification), including disulfiram.
- Unstable or serious medical illness.
- Current severe psychiatric symptoms.
- Mental retardation or another pervasive developmental disorder.
- Use of an investigational medication in the past 30 days.
- Pregnant, nursing or not using reliable contraception.
Location and Contact Information
Pennsylvania
Center for Anxiety, University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
More Information
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: November 8, 2000
ClinicalTrials.gov Identifier: NCT00006489
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Accommodations For People with PTSD (Job Accommodation Network)
- Anxiety Disorders (National Mental Health Information Center, SAMHSA, HHS)

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