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

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.

Pennsylvania
      Center for Anxiety, University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

Study ID Numbers:  NIAAAFOA12428
Record last reviewed:  April 2004
Record first received:  November 8, 2000
ClinicalTrials.gov Identifier:  NCT00006489
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-18