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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 8, 2000

Last Updated Date

November 4, 2008

Start Date ^†

December 2000

Current 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 ]

Original Primary Outcome Measures ^†

PTSD Symptom Scale – Interview
Time-Line Follow-back Interview

Change History

Complete list of historical versions of study NCT00006489 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Beck Depression Inventory
Penn Alcohol Cravings Scale
Sheehan Disability Scale

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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. Followup assessments will be completed at 9 and 12 months after treatment.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study

Condition ^†

Alcoholism
Alcohol Dependence
Post-Traumatic Stress Disorder

Intervention ^†

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

Study Arms / Comparison Groups

Active Comparator: Naltrexone alone
Active Comparator: Naltrexone with CBT for PTSD
Active Comparator: Placebo with CBT for PTSD
Placebo Comparator: Placebo alone

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

180

Estimated Completion Date

January 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility 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 followup 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 symptoms.
Mental retardation or another pervasive developmental disorder.
Use of an investigational medication in the past 30 days.
Pregnant, nursing or not using reliable contraception.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Edna B. Foa, PhD

215-746-3327

foa@mail.med.upenn.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00006489

Responsible Party

Edna B. Foa, University of Pennsylvania

Secondary IDs ^††

NIH grant R01-AA-012428

Study Sponsor ^†

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Edna B. Foa, PhD

University of Pennsylvania

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.