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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00006489 |
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.
Condition | Intervention | Phase |
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Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder |
Behavioral: Cognitive-Behavioral Therapy Drug: Naltrexone Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder |
Estimated Enrollment: | 180 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Naltrexone alone
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Drug: Naltrexone
Daily dosing 100 mg for 24 weeks
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2: Active Comparator
Naltrexone with CBT for PTSD
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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
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3: Active Comparator
Placebo with CBT for PTSD
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Behavioral: Cognitive-Behavioral Therapy
Twelve weekly 90-minute individual therapy sessions followed by 6 90-minute sessions every other week
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4: Placebo Comparator
Placebo alone
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Drug: Placebo
Pill Placebo daily dosing 24 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Edna B. Foa, PhD | 215-746-3327 | foa@mail.med.upenn.edu |
United States, Pennsylvania | |
Center for Anxiety, University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Edna B. Foa, PhD 215-746-3327 | |
Principal Investigator: Edna B. Foa, PhD |
Principal Investigator: | Edna B. Foa, PhD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Edna B. Foa ) |
Study ID Numbers: | NIAAAFOA12428, NIH grant R01-AA-012428 |
Study First Received: | November 8, 2000 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00006489 History of Changes |
Health Authority: | United States: Federal Government |
Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder Naltrexone Cognitive Behavior Therapy |
Narcotic Antagonists Stress Disorders of Environmental Origin Narcotics Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
Alcoholism Naltrexone Substance-Related Disorders Stress Disorders, Post-Traumatic Alcohol-Related Disorders Peripheral Nervous System Agents Ethanol |
Disease Physiological Effects of Drugs Narcotic Antagonists Stress Disorders of Environmental Origin Pharmacologic Actions Stress Disorders, Traumatic Pathologic Processes Anxiety Disorders Sensory System Agents |
Mental Disorders Therapeutic Uses Alcoholism Naltrexone Substance-Related Disorders Stress Disorders, Post-Traumatic Alcohol-Related Disorders Peripheral Nervous System Agents Central Nervous System Agents |