Gabapentin for Abstinence Initiation in Alcohol Dependence (GAINS)
This study is currently recruiting participants.
Verified December 2012 by New York State Psychiatric Institute
Information provided by (Responsible Party):
New York State Psychiatric Institute
First received: June 9, 2010
Last updated: December 7, 2012
Last verified: December 2012
- Gabapentin will significantly reduce the symptoms of alcohol withdrawal as compared to placebo. The primary outcome measure of alcohol withdrawal will be the Clinical Institute Withdrawal Alcohol (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, & Sellers, 1989) score.
- 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.
1. Gabapentin will be superior to placebo in reducing alcohol use as measured by secondary outcomes such as amount of drinks per day, amount of drinks per drinking day, percent days abstinent and serial measurement of gamma-glutamyl transferase (GGT) serum level.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Gabapentin for Abstinence Initiation in Alcohol Dependence
Primary Outcome Measures:
- The number of days of abstinence from alcohol [ Time Frame: 8 weeks of trial or length of patient's participation ] [ Designated as safety issue: No ]
During the course of 8 weeks the medication aims to determine whether it is effective in treating alcohol withdrawal symptoms, reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Active Comparator: Gabapentin
Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.
During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
Placebo Comparator: Placebo
Placebo capsules will be administered TID.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141049
|Substance Treatment and Research Service (STARS)
|New York, New York, United States, 10019 |
|Contact: John J. Mariani, MD 212-543-5987 email@example.com |
|Principal Investigator: John J. Mariani, MD |
|New York State Psychiatric Institute
|New York, New York, United States, 10032 |
|Contact: John J Mariani, MD 212-543-5987 firstname.lastname@example.org |
|Sub-Investigator: John J Mariani, MD |
|Principal Investigator: Frances R Levin, MD |
New York State Psychiatric Institute
||John Mariani, MD
No publications provided
||New York State Psychiatric Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 9, 2010
||December 7, 2012
||United States: Institutional Review Board
Keywords provided by New York State Psychiatric Institute:
Reducing Alcohol Consumption
Promoting abstinence in alcohol-dependent patients
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
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