Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Naltrexone; Naltrexone plus Gabapentin; Inactive Placebo
Intervention description: Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks; naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks; Placebo
Intervention MeSH terms: Naltrexone; Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alcohol dependence; Alcoholism; Heavy drinking

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.
    

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.