Expired Study
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Philadelphia, Pennsylvania 19104


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. Follow-up assessments will be completed at 9 and 12 months after treatment.


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 follow-up visits. - Aged between 18 and 65 years old. - 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. - Continued contact with an intimate partner if assault by the partner is the index trauma. - Changes in dosage or medication for any SSRI treatment in the three months prior to entering the study. - Unstable or serious medical illness. - Current severe psychiatric symptom. - Mental retardation or another pervasive developmental disorder. - Use of an investigational medication in the past 30 days. - Pregnant, nursing or not using reliable contraception.


NCT ID:

NCT00006489


Primary Contact:

Principal Investigator
Edna B. Foa, PhD
University of Pennsylvania


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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