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Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Naltrexone plus Gabapentin
Inactive Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet criteria for primary alcohol dependence including loss of control of drinking No more than one previous inpatient medical detoxification Consumes on average 5 standard drinks for men and 4 standard drinks for women Able to maintain sobriety for 4 days (with or without detox medications). Able to read and understand questionnaires and Informed Consent Lives within 50 miles of the study site Exclusion Criteria: Currently meets DSM-IV criteria for any other psychoactive substance dependency disorder except nicotine dependence Ever abused opiates Any psychoactive substance abuse, except marijuana and nicotine within the last 30 days as evidenced by subject report, collateral report, or urine drug screen. Meets DSM-IV criteria for current Axis I disorder of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, dissociative disorder or eating disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. Has current suicidal or homicidal ideation Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications. Current use of disulfiram. Clinically significant medical problems, such as cardiovascular, renal, GI or endocrine problem that would impair participation or limit medication ingestion. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days of abstinence. Sexually active females of child bearing potential who are pregnant (by urine HCG), nursing or who are not using a reliable form of birth control. Has current charges pending for a violent crime (not including DUI related offenses). Does not have a stable living situation and a reliable source of collateral reporting. Has taken an opiate antagonist drug in the last month. Has taken gabapentin in the last month or has experienced adverse effects from it at any time in the past.

Sites / Locations

  • Medical University of South Carolina, Center for Drug and Alcohol Programs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

1

2

3

Arm Description

Naltrexone plus placebo

naltrexone + gabapentin

Placebo plus placebo

Outcomes

Primary Outcome Measures

Time to Relapse to Drinking
Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
May 9, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00183196
Brief Title
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Official Title
Gabapentin as an Adjunct to Naltrexone for Alcoholism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo. All participants will receive alcohol counseling.
Detailed Description
Subjects will enter the trial after maintaining 4 days of abstinence. During this period multiple assessments will be collected. After entering the double blind treatment portion of the study, they will be evaluated weekly for the first month, then bi-weekly until week 12 and again at week 16. There will be two follow-up visits at weeks 28 and 40. Urinary riboflavin and pill counts will be utilized to determine compliance with the medication regime. Comparison(s): Naltrexone (50 mg/day) alone for 16-weeks; naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks, or inactive placebos. All subjects will receive up to 20 sessions of individual alcohol counseling.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Naltrexone plus placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
naltrexone + gabapentin
Arm Title
3
Arm Type
Sham Comparator
Arm Description
Placebo plus placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks
Intervention Type
Drug
Intervention Name(s)
Naltrexone plus Gabapentin
Intervention Description
naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks
Intervention Type
Other
Intervention Name(s)
Inactive Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to Relapse to Drinking
Description
Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet criteria for primary alcohol dependence including loss of control of drinking No more than one previous inpatient medical detoxification Consumes on average 5 standard drinks for men and 4 standard drinks for women Able to maintain sobriety for 4 days (with or without detox medications). Able to read and understand questionnaires and Informed Consent Lives within 50 miles of the study site Exclusion Criteria: Currently meets DSM-IV criteria for any other psychoactive substance dependency disorder except nicotine dependence Ever abused opiates Any psychoactive substance abuse, except marijuana and nicotine within the last 30 days as evidenced by subject report, collateral report, or urine drug screen. Meets DSM-IV criteria for current Axis I disorder of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, dissociative disorder or eating disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. Has current suicidal or homicidal ideation Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications. Current use of disulfiram. Clinically significant medical problems, such as cardiovascular, renal, GI or endocrine problem that would impair participation or limit medication ingestion. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days of abstinence. Sexually active females of child bearing potential who are pregnant (by urine HCG), nursing or who are not using a reliable form of birth control. Has current charges pending for a violent crime (not including DUI related offenses). Does not have a stable living situation and a reliable source of collateral reporting. Has taken an opiate antagonist drug in the last month. Has taken gabapentin in the last month or has experienced adverse effects from it at any time in the past.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond F. Anton, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina, Center for Drug and Alcohol Programs
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21454917
Citation
Anton RF, Myrick H, Wright TM, Latham PK, Baros AM, Waid LR, Randall PK. Gabapentin combined with naltrexone for the treatment of alcohol dependence. Am J Psychiatry. 2011 Jul;168(7):709-17. doi: 10.1176/appi.ajp.2011.10101436. Epub 2011 Mar 31.
Results Reference
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Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

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