Batki 2010.
| Trial name or title | Topiramate treatment of alcohol use disorders in veterans with post‐traumatic stress disorder (PTSD): a pilot controlled trial of augmentation therapy |
| Methods | Randomised placebo‐controlled double‐blind trial |
| Participants | 30 participants Inclusion criteria: 18 to 65 years old; both genders; current DSM‐IV diagnosis of PTSD; current DSM‐IV diagnosis of an alcohol use disorder; meeting criteria for "heavy" or "at‐risk" drinking by NIAAA thresholds; receiving treatment for PTSD; expressing desire to reduce alcohol consumption; female must have negative urine pregnancy test and must be postmenopausal or practising an effective method of birth control; having a BAC less than 0.02% Exclusion criteria: psychotic disorders, bipolar disorder, dementia or other unstable psychiatric disorders; clinically significant unstable medical conditions, including renal disease, seizure disorders, glaucoma, history of kidney stones; concurrent participation in another treatment study; female pregnant or lactating; current or within four weeks of topiramate use; current or within four weeks of medications for alcohol dependence; needing acute medical detoxification from alcohol based on a score of 12 or higher on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA‐AD); legally mandated to participate in an alcohol treatment programme; suicide attempt or suicidal ideation in the six months before enrolment; adverse event or hypersensitivity reaction to topiramate; currently treated with another anticonvulsant; individuals who in the opinion of the investigator should not be enrolled in the study because of precautions, warnings or contraindications outlined in the topiramate package insert |
| Interventions | (1) Topiramate; (2) placebo Dose: topiramate 300 mg/d Duration: 12 weeks. Country of origin: USA |
| Outcomes | Primary outcomes: change in percentage of days abstinent from alcohol Secondary outcomes: percentage of days abstinent from alcohol; changes in PTSD measures |
| Starting date | April 2010 |
| Contact information | Brooke Lasher, BA, 415‐221‐4810, ext 4954, brooke.lasher@va.gov; Steve L Batki, MD, 415‐221‐4810, ext 3671, steven.batki@ucsf.edu, University of California, San Francisco; Department of Veterans Affairs, VA Medical Center, San Francisco, California, United States 94121 |
| Notes |