Mariani 2010.

Trial name or title	Gabapentin for abstinence initiation in alcohol dependence
Methods	Randomised placebo‐controlled double‐blind trial
Participants	60 participants Inclusion criteria: between the ages of 18 and 65; meeting DSM‐IV criteria for current alcohol dependence; seeking treatment for alcohol dependence; drinking a minimum of five standard drinks for men or four standard drinks for women at least four days per week over the past 28 days; able to provide informed consent and to comply with study procedures Exclusion criteria: history of DSM‐IV diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder; diagnosis of current major depressive disorder or any other current Axis I psychiatric disorder as defined by DSM‐IV‐TR, other than alcohol dependence, that in the investigator's judgement might require intervention over the course of the study; receiving prescribed psychotropic medication; evidence of moderate to severe alcohol withdrawal (CIWA‐Ar > 13); history of allergic reaction to candidate medication; history of alcohol withdrawal seizures or alcohol withdrawal delirium; pregnancy, lactation or failure to use adequate contraceptive methods in female participants; unstable medical conditions, such as poorly controlled diabetes or hypertension (> 140/90 mmHg); current DSM‐IV‐TR diagnosis of other substance dependence, with the exception of nicotine and caffeine dependence; legally mandated to participate in an alcohol use disorder treatment programme; significant risk for suicide; participants likely, based on history, to place themselves in danger (e.g. driving while intoxicated or otherwise unwilling to follow safety precautions); renal insufficiency or abnormal renal function
Interventions	(1) Gabapentin; (2) placebo Drug dose: gabapentin up to 1200 mg/d Duration: eight weeks. Country of origin: USA
Outcomes	Primary outcome: number of days of abstinence
Starting date	August 2010
Contact information	John J. Mariani, MD, 212‐543‐5987, jm2330@columbia.edu, New York State Psychiatric Institute, New York, New York, United States 10032
Notes