Gabapentin for Abstinence Initiation in Alcohol Dependence (GAINS)

April 22, 2019 updated by: John Mariani MD, New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute
      • New York, New York, United States, 10019
        • Substance Treatment and Research Service (STARS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Neurontin
Placebo Comparator: Placebo
Placebo capsules will be administered TID.
Other: Placebo
Placebo, TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Heavy Drinking Days Per Week
Time Frame: assesed over 8 weeks, presented for week 8 of trial
percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.
assesed over 8 weeks, presented for week 8 of trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Days of Abstinence From Alcohol
Time Frame: assessed for up to 8 weeks, presented at week 8 of trial
During the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients.
assessed for up to 8 weeks, presented at week 8 of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: John Mariani, MD, NYSPI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #6123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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