Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

NCT ID: NCT00183196

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Naltrexone plus placebo

Group Type: ACTIVE_COMPARATOR

Naltrexone

Intervention Type: DRUG

Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks

2

naltrexone + gabapentin

Group Type: ACTIVE_COMPARATOR

Naltrexone plus Gabapentin

Intervention Type: DRUG

naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks

3

Placebo plus placebo

Group Type: SHAM_COMPARATOR

Inactive Placebo

Intervention Type: OTHER

Placebo

Interventions

Naltrexone

Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks

Intervention Type: 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

Intervention Type: DRUG

Inactive Placebo

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Raymond F. Anton

Distinguished University Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond F. Anton, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina, Center for Drug and Alcohol Programs

Charleston, South Carolina, United States

Countries

United States

References

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. doi: 10.1176/appi.ajp.2011.10101436. Epub 2011 Mar 31.

Reference Type: RESULT

PMID: 21454917 (View on PubMed)

Other Identifiers

5R01AA009568-14

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH RO1 AA09568

Identifier Type: -

Identifier Source: secondary_id

NIAAAANT09568-2005a

Identifier Type: -

Identifier Source: org_study_id