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

March 10, 2017 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
Time Frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
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)
Time Frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
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
Time Frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Edna B. Foa, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 8, 2000

First Submitted That Met QC Criteria

November 8, 2000

First Posted (Estimate)

November 9, 2000

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAFOA12428
  • R01AA012428 (U.S. NIH Grant/Contract)
  • NIH grant R01-AA-012428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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