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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00006489
First received: November 8, 2000
Last updated: July 3, 2012
Last verified: February 2011
History of Changes
  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 4

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:

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 ]

Enrollment: 167
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 by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 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: July 3, 2012
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 May 23, 2013