Gabapentin for Abstinence Initiation in Alcohol Dependence

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Hypotheses:

1. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back method.

Secondary Hypotheses:

1. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days abstinent.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Ethanol; Gabapentin; gamma-Aminobutyric Acid

Criteria

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.