Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Alcohol Dependence |
| Intervention | Drug: Naltrexone Drug: Naltrexone plus Gabapentin Other: Inactive Placebo |
| Phase | Phase 3 |
| Sponsor | Medical University of South Carolina |
| Responsible Party | Medical University of South Carolina |
| ClinicalTrials.gov Identifier | NCT00183196 |
| First Received | September 13, 2005 |
| Last Updated | April 23, 2013 |
| Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 13, 2005 |
|---|---|
| Last Updated Date | April 23, 2013 |
| Start Date | January 2003 |
| Estimated Primary Completion Date | June 2009 |
| Current Primary Outcome Measures | Time to Relapse to Drinking [Time Frame: 16 weeks] [Designated as safety issue: No]Time to relapse drinking which is 5 standard drinks for males and 4 standard drinks for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Alcohol Dependence |
| Intervention | Drug: Naltrexone Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks Drug: Naltrexone plus Gabapentin naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks Other: Inactive Placebo Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 150 |
| Estimated Completion Date | June 2009 |
| Estimated Primary Completion Date | December 2008 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00183196 |
|---|---|
| Other Study ID Numbers | NIAAAANT09568-2005a |
| Has Data Monitoring Committee | No |
| Information Provided By | Medical University of South Carolina |
| Study Sponsor | Medical University of South Carolina |
| Collaborators | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Investigators | Principal Investigator: Raymond F. Anton, MD Medical University of South Carolina |
| Verification Date | January 2013 |
Locations[ + expand ][ + ]
| Medical University of South Carolina, Center for Drug and Alcohol Programs | Charleston, South Carolina, United States, 29425 |
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