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.