Topiramate for Alcohol Use in Posttraumatic Stress Disorder

PTSD Clinical Trial

Official title:

A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01408641
• Other study ID #: HP-00047672
• Status: Terminated
• Phase: N/A
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease
• Posttraumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Topiramate
Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
• Placebo
Placebo capsules without topiramate

Locations

Country	Name	City	State
United States	Baltimore VA, VA Maryland Health Care System	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Heavy Drinking Days	The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.	14 weeks
Secondary	Amount of PTSD Symptoms	The Clinician Administered PTSD Scale (CAPS) contains 30 questions relating to PTSD symptoms. Each question asks about both the frequency and the severity of each symptom. These questions are split into categories. Each criterion has several questions, and scores for each criterion are added up at the end. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.	14 weeks