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

Sponsor:	University of Pennsylvania
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00006489

Purpose

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.

Condition	Intervention	Phase
Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder	Behavioral: Cognitive-Behavioral Therapy Drug: Naltrexone Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

PTSD Symptom Scale - Interview [ Time Frame: 9 and 12 months ] [ Designated as safety issue: No ]
Drinking Time Line Follow-back [ Time Frame: 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Beck Depression Inventory [ Time Frame: 9 and 12 months ] [ Designated as safety issue: No ]
Penn Alcohol Cravings Scale [ Time Frame: 9 and 12 months ] [ Designated as safety issue: No ]
Sheehan Disability Scale [ Time Frame: 9 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	December 2000
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Naltrexone alone	Drug: Naltrexone Daily dosing 100 mg for 24 weeks
Active Comparator: 2 Naltrexone with CBT for PTSD	Behavioral: Cognitive-Behavioral Therapy Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week Drug: Naltrexone Daily dosing 100 mg for 24 weeks
Active Comparator: 3 Placebo with CBT for PTSD	Behavioral: Cognitive-Behavioral Therapy Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Placebo Comparator: 4 Placebo alone	Drug: Placebo Pill Placebo daily dosing 24 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006489

Locations

United States, Pennsylvania
Center for Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Edna B. Foa, PhD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Edna B. Foa, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00006489 History of Changes
Other Study ID Numbers:	NIAAAFOA12428, R01AA012428, NIH grant R01-AA-012428
Study First Received:	November 8, 2000
Last Updated:	August 4, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Pennsylvania:

Alcoholism
Alcohol Dependence
Post-Traumatic Stress Disorder
Naltrexone
Cognitive Behavior Therapy

Additional relevant MeSH terms:

Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Anxiety Disorders
Naltrexone

Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012