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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone

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.