Back to resultsTreatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
Primary Purpose
Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Naltrexone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder, Naltrexone, Cognitive Behavior Therapy
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.
Sites / Locations
- Center for Anxiety, University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Naltrexone alone
Naltrexone with CBT for PTSD
Placebo with CBT for PTSD
Placebo alone
Arm Description
Naltrexone alone
Naltrexone with CBT for PTSD
Placebo with CBT for PTSD
Placebo alone
Outcomes
Primary Outcome Measures
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Drinking Timeline Follow-back Interview (TFBI)
The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.
Secondary Outcome Measures
Penn Alcohol Cravings Scale
The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.
Full Information
NCT ID
NCT00006489
First Posted
November 8, 2000
Last Updated
March 10, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00006489
Brief Title
Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
Official Title
Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder
Keywords
Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder, Naltrexone, Cognitive Behavior Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naltrexone alone
Arm Type
Active Comparator
Arm Description
Naltrexone alone
Arm Title
Naltrexone with CBT for PTSD
Arm Type
Active Comparator
Arm Description
Naltrexone with CBT for PTSD
Arm Title
Placebo with CBT for PTSD
Arm Type
Active Comparator
Arm Description
Placebo with CBT for PTSD
Arm Title
Placebo alone
Arm Type
Placebo Comparator
Arm Description
Placebo alone
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
Daily dosing 100 mg for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pill Placebo daily dosing 24 weeks
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
Description
The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Time Frame
Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
Title
Drinking Timeline Follow-back Interview (TFBI)
Description
The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.
Time Frame
Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
Secondary Outcome Measure Information:
Title
Penn Alcohol Cravings Scale
Description
The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.
Time Frame
Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edna B. Foa, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27930926
Citation
Zang Y, Yu J, Chazin D, Asnaani A, Zandberg LJ, Foa EB. Changes in coping behavior in a randomized controlled trial of concurrent treatment for PTSD and alcohol dependence. Behav Res Ther. 2017 Mar;90:9-15. doi: 10.1016/j.brat.2016.11.013. Epub 2016 Nov 24.
Results Reference
derived
PubMed Identifier
26905901
Citation
Kaczkurkin AN, Asnaani A, Alpert E, Foa EB. The impact of treatment condition and the lagged effects of PTSD symptom severity and alcohol use on changes in alcohol craving. Behav Res Ther. 2016 Apr;79:7-14. doi: 10.1016/j.brat.2016.02.001. Epub 2016 Feb 15.
Results Reference
derived
PubMed Identifier
23925619
Citation
Foa EB, Yusko DA, McLean CP, Suvak MK, Bux DA Jr, Oslin D, O'Brien CP, Imms P, Riggs DS, Volpicelli J. Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial. JAMA. 2013 Aug 7;310(5):488-95. doi: 10.1001/jama.2013.8268.
Results Reference
derived
PubMed Identifier
22480715
Citation
Powers MB, Gillihan SJ, Rosenfield D, Jerud AB, Foa EB. Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. J Anxiety Disord. 2012 Jun;26(5):617-23. doi: 10.1016/j.janxdis.2012.02.013. Epub 2012 Mar 3.
Results Reference
derived
Learn more about this trial
Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
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