Gabapentin for Abstinence Initiation in Alcohol Dependence (GAINS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01141049
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : January 16, 2014
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:

Primary Hypotheses:

  1. 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.
  2. 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 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Gabapentin Other: Placebo Phase 2 Phase 3

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 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 treatment of alcohol withdrawal as measured by the CIWA-Ar and 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.)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin for Abstinence Initiation in Alcohol Dependence
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Gabapentin
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.
Other Name: Neurontin
Placebo Comparator: Placebo
Placebo capsules will be administered TID.
Other: Placebo
Placebo, TID

Primary Outcome Measures :
  1. The number of days of abstinence from alcohol [ Time Frame: 8 weeks of trial or length of patient's participation ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01141049

United States, New York
Substance Treatment and Research Service (STARS)
New York, New York, United States, 10019
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Principal Investigator: John Mariani, MD NYSPI

Responsible Party: New York State Psychiatric Institute Identifier: NCT01141049     History of Changes
Other Study ID Numbers: #6123
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: July 2013

Keywords provided by New York State Psychiatric Institute:
Alcohol Withdrawal
Reducing Alcohol Consumption
Promoting abstinence in alcohol-dependent patients

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
gamma-Aminobutyric Acid
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents