| November 8, 2000 |
| November 4, 2008 |
| December 2000 |
| January 2009 (final data collection date for primary outcome measure) |
- 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 ]
|
- PTSD Symptom Scale – Interview
- Time-Line Follow-back Interview
|
| Complete list of historical versions of study NCT00006489 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Beck Depression Inventory
- Penn Alcohol Cravings Scale
- Sheehan Disability Scale
|
| |
| Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone) |
| 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. Followup assessments will be completed at 9 and 12 months after treatment. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
- Alcoholism
- Alcohol Dependence
- Post-Traumatic Stress Disorder
|
- Behavioral: Cognitive-Behavioral Therapy
- Drug: Naltrexone
- Drug: Placebo
|
- Active Comparator: Naltrexone alone
- Active Comparator: Naltrexone with CBT for PTSD
- Active Comparator: Placebo with CBT for PTSD
- Placebo Comparator: Placebo alone
|
| |
| |
| Recruiting |
| 180 |
| January 2009 |
| January 2009 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 65 Years |
| No |
|
|
| United States |
| |
| NCT00006489 |
| Edna B. Foa, University of Pennsylvania |
| NIAAAFOA12428, NIH grant R01-AA-012428 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|
| Principal Investigator: |
Edna B. Foa, PhD |
University of Pennsylvania |
|
|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| November 2008 |