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Gabapentin for Abstinence Initiation in Alcohol Dependence (GAINS)

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Withdrawal, Reducing Alcohol Consumption, Promoting abstinence in alcohol-dependent patients, Gabapentin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Substance Treatment and Research Service (STARS)
  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

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.

Placebo capsules will be administered TID.

Outcomes

Primary Outcome Measures

Percent of Heavy Drinking Days Per Week
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.

Secondary Outcome Measures

Percent Days of Abstinence From Alcohol
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.

Full Information

First Posted
June 9, 2010
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01141049
Brief Title
Gabapentin for Abstinence Initiation in Alcohol Dependence
Acronym
GAINS
Official Title
Gabapentin for Abstinence Initiation in Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol Withdrawal, Reducing Alcohol Consumption, Promoting abstinence in alcohol-dependent patients, Gabapentin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules will be administered TID.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, TID
Primary Outcome Measure Information:
Title
Percent of Heavy Drinking Days Per Week
Description
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.
Time Frame
assesed over 8 weeks, presented for week 8 of trial
Secondary Outcome Measure Information:
Title
Percent Days of Abstinence From Alcohol
Description
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.
Time Frame
assessed for up to 8 weeks, presented at week 8 of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mariani, MD
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Treatment and Research Service (STARS)
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34120336
Citation
Mariani JJ, Pavlicova M, Basaraba C, Mamczur-Fuller A, Brooks DJ, Bisaga A, Carpenter KM, Nunes EV, Levin FR. Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder. Alcohol Clin Exp Res. 2021 Aug;45(8):1639-1652. doi: 10.1111/acer.14648. Epub 2021 Jul 5.
Results Reference
derived

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Gabapentin for Abstinence Initiation in Alcohol Dependence

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