Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
Completed · Phase 4 · Has a placebo group
Conditions studied: Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder
In brief
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.
Key facts
- Study ID
- NCT00006489
- Run by
- University of Pennsylvania
- People needed
- 165
- Starts
- 2000-12-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2017-04-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Center for Anxiety, University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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