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Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Post-traumatic Stress Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Scott F. coffey, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01409707
First received: August 2, 2011
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition.


Condition Intervention
Alcohol Dependence
Posttraumatic Stress Disorder
 Behavioral: Prolonged exposure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Impact of Event Scale-Revised [ Time Frame: one-week ] [ Designated as safety issue: No ]
    Measure of PTSD symptoms.

  • Timeline Follow Back [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Drug and alcohol consumption in the prior 90 days


Estimated Enrollment: 250
Study Start Date: July 2008
Estimated Study Completion Date: May 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Prolonged exposure
    cognitive behavioral therapy for PTSD
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients meeting criteria for alcohol dependence and PTSD seeking treatment at a local residential treatment facility.

Criteria

Inclusion Criteria:

  • Current PTSD
  • Current Alcohol Dependence
  • at least one heavy drinking day in the past 60 days

Exclusion Criteria:

  • Psychotic disorder
  • Untreated bi-polar disorder
  • benzodiazepine use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409707

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Scott F. Coffey, Ph.D. University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Scott F. coffey, Professor and Director, Division of Psychology, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01409707     History of Changes
Other Study ID Numbers: 2007-0071, R01AA016816
Study First Received: August 2, 2011
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
 Substance-Related Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 19, 2013