NCT00006489

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

Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism
• Alcohol Dependence
• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-Behavioral Therapy	Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
DRUG	Naltrexone	Daily dosing 100 mg for 24 weeks
DRUG	Placebo	Pill Placebo daily dosing 24 weeks

Timeline

• Start date: 2000-12-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2000-11-09
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States