Phase 4
Completed N=165
Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
Alcoholism · alcohol dependence · Post-Traumatic Stress Disorder
Source: ClinicalTrials.gov NCT00006489 ↗
Enrolled (actual)
165
Serious AEs
7.3%
Results posted
Apr 2017
Primary outcomePrimary: Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) — 27.1; 30.3; 27.7; 27.5 units on a scale
◆ Published Evidence
Highly cited
262citations · ~20 / year
Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial.
Summary
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.
Linked Publications (4)
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Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial.
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Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence.
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The impact of treatment condition and the lagged effects of PTSD symptom severity and alcohol use on changes in alcohol craving.
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Changes in coping behavior in a randomized controlled trial of concurrent treatment for PTSD and alcohol dependence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) |
27.1; 30.3; 27.7; 27.5; 15.3; 12.2 | — |
| PRIMARY Drinking Timeline Follow-back Interview (TFBI) |
75.4; 71.2; 78.6; 74.1; 3.5; 7.3 | — |
| SECONDARY Penn Alcohol Cravings Scale |
17.7; 17.9; 19.2; 18.7; 8.0; 5.1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00006489) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.