Topiramate for Alcohol Use in Posttraumatic Stress Disorder

NCT01408641 | Terminated Results DMC

• 1 other identifier: HP-00047672
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Dependence; Alcoholism; Alcohol Abuse; Alcohol Use Disorder; PTSD; Posttraumatic Stress Disorder

Keywords

topiramate; PTSD; drinking; alcohol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amount of PTSD Symptoms

  14 weeks

Study Arms (2)

Topiramate

EXPERIMENTAL

Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.

Drug: Topiramate

Placebo (Sugar Pill)

PLACEBO COMPARATOR

Placebo arm will receive matching capsules without topiramate.

Drug: Placebo

Interventions

Topiramate DRUG

Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.

Also known as: Topamax

Topiramate

Placebo DRUG

Placebo capsules without topiramate

Placebo (Sugar Pill)

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Baltimore VA, VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Bernard Fischer, M.D.
• Organization: FDA

Bernard.Fischer@fda.hhs.gov

240-402-4511

Study Officials

• Bernard A Fischer, M.D.

  Department of Veterans Affairs, University of Maryland School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Maryland Psychiatric Research Center, Outpatient Research Program

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 3, 2011
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 3, 2022
• Results First Posted: May 24, 2018

Record last verified: 2022-03

Locations

US (1)