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Completed

NCT Number: NCT00006489

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

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.

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Key information

Conditions

Alcoholism Alcohol Dependence Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Post-traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Anxiety, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

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

Naltrexone

Drug

Daily dosing 100 mg for 24 weeks

Placebo

Drug

Pill Placebo daily dosing 24 weeks

Primary outcomes

  1. Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)

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

    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.

  2. Drinking Timeline Follow-back Interview (TFBI)

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

    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 outcomes

  1. Penn Alcohol Cravings Scale

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

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2000
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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