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

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Alcoholism; Post-Traumatic Stress Disorder; Alcohol Dependence

Treatments: Behavioral: Cognitive-Behavioral Therapy; Drug: Naltrexone; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006489

R01AA012428 (U.S. NIH Grant/Contract)

NIAAAFOA12428

NIH grant R01-AA-012428

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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165 participants in 4 patient groups, including a placebo group

Naltrexone alone

Active Comparator group

Description:

Naltrexone alone

Treatment:

Drug: Naltrexone

Naltrexone with CBT for PTSD

Active Comparator group

Description:

Naltrexone with CBT for PTSD

Treatment:

Drug: Naltrexone

Behavioral: Cognitive-Behavioral Therapy

Placebo with CBT for PTSD

Active Comparator group

Description:

Placebo with CBT for PTSD

Treatment:

Behavioral: Cognitive-Behavioral Therapy

Placebo alone

Placebo Comparator group

Description:

Placebo alone

Treatment:

Drug: Placebo