Alcohol Abuse, Alcohol Dependence, Alcoholism, Alcohol Use Disorder, Posttraumatic Stress Disorder, PTSD
Conditions
Keywords
topiramate, PTSD, drinking, alcohol
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.
Interventions
DRUGTopiramate
Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
DRUGPlacebo
Placebo capsules without topiramate
Sponsors
US Department of Veterans Affairs
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Heavy Drinking Days | 14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of PTSD Symptoms | 14 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Three participants were withdrawn prior to assignment to a treatment group. Two did not return for study visits after signing consent and one did not meet eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| Topiramate Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose. | 1 |
| Placebo (Sugar Pill) Placebo arm will receive matching capsules without topiramate.
Placebo: Placebo capsules without topiramate | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Topiramate | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
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.
Time frame: 14 weeks
Population: There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013.
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.
Time frame: 14 weeks
Population: There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013.