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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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ClinicalTrials.gov Identifier: NCT00183196
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : May 30, 2013
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Naltrexone Drug: Naltrexone plus Gabapentin Other: Inactive Placebo Phase 3

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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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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
 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
 Other: Inactive Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, South Carolina
Medical University of South Carolina, Center for Drug and Alcohol Programs
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Raymond F. Anton, MD Medical University of South Carolina
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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