Ciraulo 2009.
| Trial name or title | A double‐blind, placebo‐controlled, parallel‐group design trial of: levetiracetam, zonisamide, topiramate and placebo control for the treatment of alcohol‐dependent subjects |
| Methods | Randomised placebo‐controlled double‐blind trial |
| Participants | Inclusion criteria: 21 to 65 years of age; both genders; DSM‐IV‐TR diagnosis of alcohol dependence; at least 28 standard drinks per week for women or 35 drinks per week for men; able to provide informed consent, comprehend and follow study procedures; negative urine toxicological screen for opioids, cocaine, amphetamines, methamphetamine and benzodiazepines; score > eight on the Alcohol Use Disorder Identification Test (AUDIT); suitable for outpatient management of alcoholism; expressing desire to stop drinking or reduce alcohol consumption; women must be postmenopausal or must be using an effective method of birth control Exclusion criteria: dependent on DSM IV‐TR drugs or substances other than ethanol, nicotine or caffeine; DSM IV‐TR diagnosis of any current Axis I diagnosis other than alcohol, nicotine or caffeine dependence requiring intervention interfering with the course of the study; receiving inpatient treatment for alcohol dependence, other than alcohol detoxification; score of 10 or greater on the CIWA‐Ar; being treated with acamprosate, disulfiram, naltrexone, antipsychotic, anticonvulsant, sedative‐hypnotics, opioids, psychomotor stimulant‐amphetamine derivatives, methylphenidate; legally mandated to participate in an alcohol treatment programme; use of any medication known to inhibit or induce cytochrome P450 3A4 enzymes; has attempted suicide or has had suicidal ideation; renal disease or history of kidney stones; AST or ALT > three times upper limit of normal range; history of significant neurological disorder; pregnant or lactating; clinically significant medical conditions precluding administration of study medications or limiting participation in the clinical trial; history of treatment with levetiracetam, topiramate or zonisamide; score of 25 or less on the Folstein Mini Mental Examination; history of anticonvulsant‐induced rash; taking drugs such as sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides and loop diuretics; reporting average drinks per day within the guidelines for safe levels of alcohol consumption; having a "sulfa" allergy |
| Interventions | (1) Levetiracetam; (2) zonisamide, (3) topiramate, (4) placebo Drug dose: leviracetam 2000 mg/d; zonisamide 2000 to 4000 mg/d; topiramate 300 mg/d Duration: 14 weeks. Country of origin: USA |
| Outcomes | Primary outcome: mean number of drinks consumed per day Secondary outcomes: mean levels of attention and verbal fluency and composite measure of neurotoxicity |
| Starting date | May 2009 |
| Contact information | Megan Putnam, 617‐414‐1990, megan.putnam@bmc.org, Boston University School of Medicine, Massachusetts, United States 02118 |
| Notes |