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Treatment for Alcoholism and Post-Traumatic Stress Disorder (naltrexone) - Article


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Post Traumatic Stress Disorder/ptsd

 




Clinical Trial: Treatment for Alcoholism and Post-Traumatic Stress Disorder (naltrexone)

This study is currently recruiting patients.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

Further Study Details: 

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
Dr. Edna Foa  215-746-3327 

More Information

Study ID Numbers:  NIAAAFOA12428
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



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November 28, 2009



Page Updated: September 6, 2005
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