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

Phase 4

Completed

Interventions: Drug: Naltrexone
Behavioral: Cognitive-Behavioral Therapy
Drug: Placebo

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Naltrexone alone	Naltrexone	Naltrexone alone
Naltrexone with CBT for PTSD	Cognitive-Behavioral Therapy	Naltrexone with CBT for PTSD
Naltrexone with CBT for PTSD	Naltrexone	Naltrexone with CBT for PTSD
Placebo with CBT for PTSD	Cognitive-Behavioral Therapy	Placebo with CBT for PTSD
Placebo alone	Placebo	Placebo alone

Primary Outcome Measures

Name	Time	Method
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)	Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)	The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Drinking Timeline Follow-back Interview (TFBI)	Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)	The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.

Secondary Outcome Measures

Name	Time	Method
Penn Alcohol Cravings Scale	Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)	The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.