Status:
COMPLETED
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 bloc...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00183196
Start Date
January 1 2003
End Date
June 1 2009
Last Update
June 7 2018
Active Locations (1)
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1
Medical University of South Carolina, Center for Drug and Alcohol Programs
Charleston, South Carolina, United States, 29425