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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2011-02-28

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.

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Detailed Description

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Conditions

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Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Naltrexone alone

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

Daily dosing 100 mg for 24 weeks

Naltrexone with CBT for PTSD

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week

Naltrexone

Intervention Type DRUG

Daily dosing 100 mg for 24 weeks

Placebo with CBT for PTSD

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week

Placebo alone

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pill Placebo daily dosing 24 weeks

Interventions

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Cognitive-Behavioral Therapy

Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week

Intervention Type BEHAVIORAL

Naltrexone

Daily dosing 100 mg for 24 weeks

Intervention Type DRUG

Placebo

Pill Placebo daily dosing 24 weeks

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No