Status:
COMPLETED
Gabapentin for Abstinence Initiation in Alcohol Dependence
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 da...
Detailed Description
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01141049
Start Date
August 1 2010
End Date
December 1 2012
Last Update
April 24 2019
Active Locations (2)
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1
Substance Treatment and Research Service (STARS)
New York, New York, United States, 10019
2
New York State Psychiatric Institute
New York, New York, United States, 10032