Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
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ClinicalTrials.gov Identifier: NCT00183196 |
Recruitment Status
:
Completed
First Posted
: September 16, 2005
Results First Posted
: May 30, 2013
Last Update Posted
: April 15, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Dependence | Drug: Naltrexone Drug: Naltrexone plus Gabapentin Other: Inactive Placebo | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Gabapentin as an Adjunct to Naltrexone for Alcoholism |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Naltrexone plus placebo
|
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
|
Active Comparator: 2
naltrexone + gabapentin
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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
|
Sham Comparator: 3
Placebo plus placebo
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Other: Inactive Placebo
Placebo
|
- Time to Relapse to Drinking [ Time Frame: 16 weeks ]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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183196
United States, South Carolina | |
Medical University of South Carolina, Center for Drug and Alcohol Programs | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Raymond F. Anton, MD | Medical University of South Carolina |
Publications of Results:
Responsible Party: | Raymond F. Anton, Distinguished University Professor, Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00183196 History of Changes |
Other Study ID Numbers: |
NIAAAANT09568-2005a 5R01AA009568-14 ( U.S. NIH Grant/Contract ) NIH RO1 AA09568 |
First Posted: | September 16, 2005 Key Record Dates |
Results First Posted: | May 30, 2013 |
Last Update Posted: | April 15, 2016 |
Last Verified: | March 2016 |
Keywords provided by Raymond F. Anton, Medical University of South Carolina:
Alcohol dependence Alcoholism Heavy drinking |
Additional relevant MeSH terms:
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone Gabapentin gamma-Aminobutyric Acid Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents GABA Agents |