Gabapentin for Abstinence Initiation in Alcohol Dependence

In an 8-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of gabapentin in the treatment of alcohol dependence will be studied in 60 patients. Participants will be randomly assigned to treatment under double-blind conditions with either 1) a fixed dosing schedule of gabapentin or 2) placebo. All participants will receive weekly supportive behavioral treatment that promotes abstinence from alcohol and other substances, encourages mutual-support meeting attendance, and facilitates compliance with study medication. The primary outcome measures will be: the reduction of heavy drinking days per week as measured by the timeline follow-back method.

Participants will be alcohol-dependent men and nonpregnant women who report drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days. The daily minimum drinking requirements are consistent with the commonly accepted definition of "binge drinking." A minimum requirement of having a heavy drinking episode 4 days a week would select for a population of individuals who are drinking excessively more days than not. A minimum threshold of weekly alcohol use is set to prevent a "floor effect" (i.e. participants with minimal alcohol use at baseline would be unable to demonstrate significant improvement.)

Inclusion criteria

• Between the ages of 18-65.
• Meets DSM-IV criteria for current alcohol dependence.
• Seeking treatment for alcohol dependence.
• Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days.
• Able to provide informed consent and comply with study procedures.

Exclusion criteria

• Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.
• A 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 judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
• Patients currently taking prescribed psychotropic medications that would be disrupted by study medication or by an effort to discontinue alcohol use.
• Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13.
• History of allergic reaction to candidate medication (gabapentin).
• History of alcohol withdrawal seizures or alcohol withdrawal delirium.
• Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients who are currently engaging in sexual activity with men.
• Unstable medical conditions, such as poorly controlled diabetes or hypertension (> 140/90 mm Hg), which might make participation hazardous.
• Subjects who have a current DSM-IV-TR diagnosis of other substance dependence, with the exception of nicotine and caffeine dependence. A diagnosis of substance abuse will not be exclusionary unless significant illicit substance use is present.
• Are legally mandated to participate in an alcohol use disorder treatment program.
• Who by history and current assessment represent a significant risk for suicide.
• Subjects who are likely, based on history, to place themselves in danger (e.g., driving while intoxicated or otherwise being unwilling to follow safety precautions).
• Renal insufficiency or abnormal renal function.