At a glance
ClinicalIndex Comparison Record- ✓Meets criteria for both alcohol dependence and post-traumatic stress disorder
- ✓Heavy drinking in past 30 days (average >12 drinks/week with ≥1 day of ≥4 drinks)
- ✓Successfully completed medical detoxification
- ✓Clinically significant trauma-related symptoms
- ✕Current substance dependence other than alcohol, nicotine, or cannabis
- ✕Evidence of opiate use in past 30 days
- ✕Significant risk of violence or serious violent behavior in past year
- ✕Continued contact with intimate partner if that partner is the source of index trauma (assault)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder
In Brief
A Phase 4 clinical trial evaluating Cognitive-Behavioral Therapy, Naltrexone, and 1 other intervention for Alcoholism and 2 related conditions. Completed, enrolled 165 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Daily dosing 100 mg for 24 weeks
Pill Placebo daily dosing 24 weeks