Clinical trial NCT00006489: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Alcohol Dependence
Post-Traumatic Stress Disorder
Keywords: Alcoholism
Alcohol Dependence
Post-Traumatic Stress Disorder
Naltrexone
Cognitive Behavior Therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2000-11-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
timeFrame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
measure: Drinking Timeline Follow-back Interview (TFBI)
timeFrame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
Secondary outcomes:
measure: Penn Alcohol Cravings Scale
timeFrame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Anxiety, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Edna B. Foa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.