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

NCT00006489 | Completed Phase 4 Results DMC

• 3 other identifiers: NIAAAFOA12428R01AA012428NIH grant R01-AA-012428
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism; Alcohol Dependence; Post-Traumatic Stress Disorder

Keywords

Alcoholism; Alcohol Dependence; Post-Traumatic Stress Disorder; Naltrexone; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

• 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.

  Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

Secondary Outcomes (1)

• Penn Alcohol Cravings Scale

  Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

Study Arms (4)

Naltrexone alone

ACTIVE COMPARATOR

Naltrexone alone

Drug: Naltrexone

Naltrexone with CBT for PTSD

ACTIVE COMPARATOR

Naltrexone with CBT for PTSD

Behavioral: Cognitive-Behavioral Therapy; Drug: Naltrexone

Placebo with CBT for PTSD

ACTIVE COMPARATOR

Placebo with CBT for PTSD

Behavioral: Cognitive-Behavioral Therapy

Placebo alone

PLACEBO COMPARATOR

Placebo alone

Drug: Placebo

Interventions

Cognitive-Behavioral Therapy BEHAVIORAL

Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week

Naltrexone with CBT for PTSD; Placebo with CBT for PTSD

Naltrexone DRUG

Daily dosing 100 mg for 24 weeks

Naltrexone alone; Naltrexone with CBT for PTSD

Placebo DRUG

Pill Placebo daily dosing 24 weeks

Placebo alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for Anxiety, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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.

  PMID: 27930926 DERIVED

• 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.

  PMID: 26905901 DERIVED

• 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.

  PMID: 23925619 DERIVED

• 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.

  PMID: 22480715 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Edna Foa
• Organization: University of Pennsylvania

foa@mail.med.upenn.edu

215-746-3327

Study Officials

• Edna B. Foa, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2000
• First Posted: November 9, 2000
• Study Start: December 1, 2000
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03

Locations

US (1)