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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy
* Drug: Naltrexone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naltrexone alone<br>Naltrexone alone | Drug: Naltrexone<br>* Daily dosing 100 mg for 24 weeks<br>|
| Active Comparator: Naltrexone with CBT for PTSD<br>Naltrexone with CBT for PTSD | Behavioral: Cognitive-Behavioral Therapy<br>* Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week<br>Drug: Naltrexone<br>* Daily dosing 100 mg for 24 weeks<br>|
| Active Comparator: Placebo with CBT for PTSD<br>Placebo with CBT for PTSD | Behavioral: Cognitive-Behavioral Therapy<br>* Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week<br>|
| Placebo Comparator: Placebo alone<br>Placebo alone | Drug: Placebo<br>* Pill Placebo daily dosing 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) | 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. | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) | 
| Drinking Timeline Follow-back Interview (TFBI) | 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. | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penn Alcohol Cravings Scale | 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. | Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder, Naltrexone, Cognitive Behavior Therapy