Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Gabapentin as an Adjunct to Naltrexone for Alcoholism
3 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2003
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
May 30, 2013
CompletedJune 7, 2018
May 1, 2018
5.9 years
September 13, 2005
November 20, 2012
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
16 weeks
Study Arms (3)
1
ACTIVE COMPARATORNaltrexone plus placebo
2
ACTIVE COMPARATORnaltrexone + gabapentin
3
SHAM COMPARATORPlacebo plus placebo
Interventions
Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks
naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina, Center for Drug and Alcohol Programs
Charleston, South Carolina, 29425, United States
Related Publications (1)
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.
PMID: 21454917RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Raymond F. Anton, MD
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond F. Anton, MD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished University Professor
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
January 1, 2003
Primary Completion
December 1, 2008
Study Completion
June 1, 2009
Last Updated
June 7, 2018
Results First Posted
May 30, 2013
Record last verified: 2018-05