Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone - Full Text View

Sponsor:	Medical University of South Carolina
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00183196

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	Intervention	Phase
Alcohol Dependence	Drug: Naltrexone Drug: Naltrexone plus Gabapentin Other: Inactive Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Gabapentin as an Adjunct to Naltrexone for Alcoholism

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Anxiety

Drug Information available for: Naltrexone Naltrexone hydrochloride Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Time to relapse to drinking [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Symptoms such as difficulty falling asleep and/or staying asleep, irritability and nervousness as measured by a symptom checklist and specific scales. [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent days drinking [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Drinks per drinking day [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Retention in the protocol [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Craving for alcohol [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
CDT and GGT measured as change from baseline [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Psychological and general health functioning as measured by the Beck Anxiety and Depression scales [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Consequences of drinking as measured by the DRINC score at week 16 [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Urinary riboflavin as a measure of medication compliance [ Time Frame: 16 weeks, 28 weeks, and 40 weeks ] [ Designated as safety issue: No ]
Measure: Liver function tests (ALT and AST) [ Time Frame: 16 weeks, 28 and 40 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	January 2003
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Medical University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Mar 31.

Responsible Party:	Raymond F. Anton, MD, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00183196 History of Changes
Other Study ID Numbers:	NIAAAANT09568-2005a, 5R01AA009568-14, NIH RO1 AA09568
Study First Received:	September 13, 2005
Last Updated:	December 9, 2009
Health Authority:	United States: Federal Government

Keywords provided by Medical University of South Carolina:

Alcohol dependence
Alcoholism
Heavy drinking

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Gabapentin
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Anticonvulsants

Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 09, 2012