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

Alcoholism Clinical Trial

Official title:

Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006489
• Other study ID #: NIAAAFOA12428
• Secondary ID: R01AA012428NIH g
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2000
• Last updated: July 3, 2012
• Start date: December 2000
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
• Placebo
Pill Placebo daily dosing 24 weeks

Locations

Country	Name	City	State
United States	Center for Anxiety, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptom Scale - Interview		9 and 12 months	No
Primary	Drinking Time Line Follow-back		9 and 12 months	No
Secondary	Beck Depression Inventory		9 and 12 months	No
Secondary	Penn Alcohol Cravings Scale		9 and 12 months	No
Secondary	Sheehan Disability Scale		9 and 12 months	No