A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD

NCT01749215 | Completed Phase 4 Results DMC

• 2 other identifiers: PT110423W81XWH-11-PHTBI-BAPHA
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

Conditions

Alcohol Dependence; Posttraumatic Stress Disorder (PTSD)

Keywords

pharmacotherapy; alcohol dependence; Veterans

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)

  Timeline Followback (TLFB) data was recorded using a calendar, with participants providing retrospective reports of daily drinking over the past week(s). The percent of heavy drinking days per week was calculated from the calendar data. The change in percentage of heavy drinking days was calculated by subtracting Week 0 (baseline) data from Week 12. Negative scores indicate improvement.

  Baseline to Week 12

Secondary Outcomes (4)

• Change in PTSD Symptom Severity as Assessed by the PTSD Checklist (PCL)

  Baseline to Week 12

• Change in Impulsivity as Assessed by Delay Discounting (DD)

  Baseline to Week 12

• Change in Risk-taking Behavior as Assessed by the Balloon Analogue Risk Task (BART)

  Baseline to Week 12

• Change in Decision-making Behavior as Assessed by the Iowa Gambling Task (IGT)

  Baseline to Week 12

Study Arms (2)

Topiramate

EXPERIMENTAL

Topiramate capsules daily - up to 300 mg

Drug: Topiramate; Behavioral: Medical Management

Placebo

PLACEBO COMPARATOR

Placebo capsules daily - up to 300 mg

Drug: placebo; Behavioral: Medical Management

Interventions

Topiramate DRUG

Experimental study drug

Topiramate

placebo DRUG

Placebo comparator

Placebo

Medical Management BEHAVIORAL

Brief alcohol counseling

Placebo; Topiramate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female veterans
• Ages18 to 69 (inclusive)
• Current DSM-IV diagnosis of PTSD
• Current (past month) DSM-IV diagnosis of an Alcohol Dependence
• Level of drinking must meet criteria for "at-risk " or "heavy" drinking by NIAAA threshold (NIAAA 2007): at least 15 standard drinks per week on average over the 4 weeks prior to study entry for men and at least 8 standard drinks per week on average for women.
• Subjects must express a desire to reduce alcohol consumption with the possible long-term goal of abstinence.
• Female subjects must have a negative urine pregnancy test and must be either postmenopausal for at least one year, or practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)
• Subjects must have a Breath Alcohol Concentration (BAC) of \< 0.02% when signing informed consent.

You may not qualify if:

• Psychotic disorders, bipolar disorder, dementia, or other psychiatric disorders judged to be unstable.
• Subjects known to have clinically significant unstable medical conditions, including but not limited to:
• Clinically significant renal disease and/or impaired renal function as defined by clinically significant elevation of blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of \< 60 mL/min
• AST and/or ALT \>5 times the upper limit of the normal range and/or an increased serum bilirubin \>2 times the upper limit of normal.
• Seizure disorders
• History of glaucoma.
• History of kidney stones.
• Concurrent participation in another treatment study.
• Female patients who are pregnant or lactating.
• Current Topiramate use or use within the past 4 weeks.
• Current medications for alcohol dependence (disulfiram, naltrexone, or acamprosate) or use in the past week.
• Needing acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD);
• Subjects who are legally mandated to participate in an alcohol treatment program.
• Subjects who have had a suicide attempt in the past 6 months or suicidal ideation in the 90 days prior to enrollment.
• Subjects who have previously been treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate,

Sponsors & Collaborators

• University of California, San Francisco: lead
• United States Department of Defense: collaborator
• San Francisco Veterans Affairs Medical Center: collaborator
• Northern California Institute of Research and Education: collaborator

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Topiramate; Practice Management, Medical

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; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Steven L. Batki
• Organization: University of California, San Francisco/San Francisco VA Healthcare System

steven.batki@ucsf.edu

415-221-4810

Study Officials

• Steven L. Batki, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: December 13, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-05

Locations

US (1)