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Gabapentin Treatment of Alcohol Dependence

Primary Purpose

Alcoholism, Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin 900mg
behavioral counseling
placebo
gabapentin 1800mg
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcohol, Alcohol treatment, Alcoholism, Alcohol Dependence

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women over age 18 with alcohol dependence

Exclusion Criteria:

  • Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
  • Significant medical disorders that will increase potential risk or interfere with study participation
  • Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
  • Treatment with an investigational drug in the last month.

Sites / Locations

  • The Scripps Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

gabapentin 900mg daily

gabapentin 1800mg daily

placebo daily

Arm Description

900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks

placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Outcomes

Primary Outcome Measures

Drinking
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).

Secondary Outcome Measures

Mood
Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.
Sleep
The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.
Craving
Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.

Full Information

First Posted
October 20, 2006
Last Updated
November 7, 2014
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00391716
Brief Title
Gabapentin Treatment of Alcohol Dependence
Official Title
Gabapentin Treatment of Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Gabapentin treatment for alcohol dependence
Detailed Description
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Dependence
Keywords
Alcohol, Alcohol treatment, Alcoholism, Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gabapentin 900mg daily
Arm Type
Experimental
Arm Description
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Arm Title
gabapentin 1800mg daily
Arm Type
Experimental
Arm Description
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
Arm Title
placebo daily
Arm Type
Placebo Comparator
Arm Description
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Gabapentin 900mg
Other Intervention Name(s)
Neurontin
Intervention Description
900 mg gabapentin daily for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
behavioral counseling
Other Intervention Name(s)
alcoholfree.info
Intervention Description
The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
lactose capsule
Intervention Description
lactose capsule compounded to mimic gabapentin capsules
Intervention Type
Drug
Intervention Name(s)
gabapentin 1800mg
Other Intervention Name(s)
Neurontin
Intervention Description
1800 mg gabapentin daily for 12 weeks
Primary Outcome Measure Information:
Title
Drinking
Description
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
Time Frame
12-week
Secondary Outcome Measure Information:
Title
Mood
Description
Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.
Time Frame
12-week
Title
Sleep
Description
The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.
Time Frame
12-week
Title
Craving
Description
Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.
Time Frame
12-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women over age 18 with alcohol dependence Exclusion Criteria: Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances Significant medical disorders that will increase potential risk or interfere with study participation Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control Treatment with an investigational drug in the last month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Mason, PhD
Organizational Affiliation
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24190578
Citation
Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.
Results Reference
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Learn more about this trial

Gabapentin Treatment of Alcohol Dependence

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