Phase 4 N=165 Randomized Triple-blind Treatment

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

Alcoholism · Alcohol Dependence · Post-Traumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00006489 ↗

Enrolled (actual)

165

Serious AEs

7.3%

Results posted

Apr 2017

Primary outcome: Primary: Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) — 27.1; 30.3; 27.7; 27.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cognitive-Behavioral Therapy (Behavioral); Naltrexone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Feb 2011

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00006489). 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.