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



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

For Condition: Post-Traumatic Stress Disorder,Alcoholism
Status: Recruiting
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 200

Location and Contact Information:

Center for Anxiety, University of Pennsylvania *Recruiting*
Philadelphia,  Pennsylvania,  19104
United States
Recruiting Dr.  Foa 215-746-3327


Additional Information:
Study ID Numbers:  NIAAAFOA12428; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006489

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