Official Title: “Gabapentin as an Adjunct to Naltrexone for Alcoholism”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Naltrexone plus placebo
• Active Comparator: 2
  • naltrexone + gabapentin
• Sham Comparator: 3
  • Placebo plus placebo

Primary Measures

• Time to relapse to drinking
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    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
    Safety Issue?: Yes

Secondary Measures

• Percent days drinking
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    Safety Issue?: No
• Drinks per drinking day
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    Safety Issue?: No
• Retention in the protocol
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    Safety Issue?: No
• Craving for alcohol
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    Safety Issue?: No
• CDT and GGT measured as change from baseline
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    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
    Safety Issue?: No
• Consequences of drinking as measured by the DRINC score at week 16
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    Safety Issue?: No
• Urinary riboflavin as a measure of medication compliance
  • Time Frame: 16 weeks, 28 weeks, and 40 weeks
    Safety Issue?: No
• Measure: Liver function tests (ALT and AST)
  • Time Frame: 16 weeks, 28 and 40 weeks
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Overall Clinical Trial Officials and Contacts

Raymond F. Anton, MD Principal Investigator Medical University of South Carolina  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00183196

Study ID Number: NIAAAANT09568-2005a

ClinicalTrials.gov Identifier: NCT00183196

Health Authority: United States: Federal Government