Topiramate for Alcohol Use in Posttraumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bernard Fischer, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01408641
First received: August 1, 2011
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.


Condition Intervention
Alcohol Dependence
Alcoholism
Alcohol Abuse
Alcohol Use Disorder
PTSD
Posttraumatic Stress Disorder
Drug: Topiramate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Number of days of Heavy Drinking [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Days Abstinent [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Amount of PTSD Symptoms [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Number of Memory/Cognitive Complaints [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topiramate
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Drug: Topiramate
Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
Other Name: Topamax
Placebo Comparator: Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Drug: Placebo
Placebo capsules without topiramate

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Ages 21-64
  • Diagnosis of PTSD via a score of 50 or higher on the Clinician Administered PTSD Scale (CAPS)
  • Alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the Timeline Follow-Back Interview
  • A desire to reduce drinking behavior
  • Any Race/Ethnicity

Exclusion Criteria:

  • Currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide)
  • Currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate
  • Change in benzodiazepine dose within the previous 3 months
  • Change in other (non-benzodiazepine) medication dose within the last 4 weeks
  • Seizure disorder documented in the medical record
  • Head trauma with loss of consciousness for greater than 30 minutes -or- a diagnosis of post-concussive syndrome documented in the medical record
  • Suicide attempt within the previous 3 months or suicidal ideation within the previous 4 weeks
  • A history of kidney stones
  • A history of glaucoma
  • ALT or AST liver enzymes elevated more than twice the upper limit of normal
  • More than 4 unsuccessful attempts at inpatient alcohol treatment
  • Medically unstable (including significant hypertension despite adequate treatment)
  • A history of delirium tremens ("DTs") or alcohol withdrawal seizure
  • Compulsory treatment to avoid legal consequences (e.g. imprisonment)
  • Currently in a setting without access to alcohol (e.g. locked inpatient unit)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408641

Contacts
Contact: Jennifer Duncan (410)637-1432 Jennifer.Duncan5@va.gov

Locations
United States, Maryland
Baltimore VA, VA Maryland Health Care System Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Bernard A Fischer, M.D.         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Bernard A Fischer, M.D. Department of Veterans Affairs, University of Maryland School of Medicine
  More Information

No publications provided

Responsible Party: Bernard Fischer, MD, Physician, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier: NCT01408641     History of Changes
Other Study ID Numbers: HP-00047672 (UMD IRB#)
Study First Received: August 1, 2011
Last Updated: September 10, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Maryland:
topiramate
PTSD
drinking
alcohol

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Anxiety Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 22, 2014