An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Placebo; Naltrexone; Naltrexone + Aripiprazole
Intervention description: placebo; Naltrexone (25mg or 50 mg per titration schedule); Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
Intervention MeSH terms: Naltrexone; Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alcohol Dependence; Alcoholism; Naltrexone; Aripiprazole; Substance Abuse

Summary:

      The principal aim of this exploratory study is to examine whether the addition of
      aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week
      randomized, placebo-controlled clinical trial, in which all subjects will be provided medical
      management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication
      treatment will reduce drinking compared to placebo treatment alone in the context of medical
      management and whether naltrexone plus aripiprazole will reduce drinking compared to
      naltrexone treatment alone in the context of medical management.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 70

          2. Subjects will meet criteria for primary alcohol dependence operationalized as follows:

             A. Meets the DSM IV criteria for alcohol dependence including loss of control over
             drinking (criterion 3) B. Has not had more than one previous inpatient medical
             detoxification

          3. Consumes, on average, at least 10 standard drinks per drinking day for men and 8
             drinks per day for women in the 90 days pre-screening (to select an appropriately
             heavy drinking population)

          4. Able to maintain sobriety for four days (with or without the aid of alcohol
             detoxification medications) as determined by self report, collateral report, and
             breathalyzer measurements

          5. Able to read and understand questionnaires and informed consent

          6. Lives within approximately 50 miles of the study site -

        Exclusion Criteria:

          1. Currently meets DSM IV criteria for any other psychoactive substance dependency
             disorder except nicotine dependence

          2. Ever abused opiates

          3. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30
             days as evidenced by subject report, collateral report, or urine drug screen

          4. Meets DSM IV criteria for current axis I disorders of major depression, panic
             disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar
             affective disorder, schizophrenia, or any other psychotic disorder or organic mental
             disorder

          5. Meets DSM IV current criteria for dissociative disorder or eating disorders

          6. Has current suicidal ideation or homicidal ideation

          7. Need for maintenance or acute treatment with any psychoactive medication including
             anti-seizure medications

          8. Current use of disulfiram

          9. Clinically significant medical problems such as cardiovascular, renal, GI, or
             endocrine problem that would impair participation or limit medication ingestion

         10. 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 abstinence

         11. Sexually active female of child-bearing potential who is pregnant (by urine HCG),
             nursing, or who is not using a reliable form of birth control

         12. Has current charges pending for a violent crime (not including DUI-related offenses)

         13. Does not have a stable living situation and a reliable source of collateral reporting

         14. Has taken an opiate antagonist drug in the last month

         15. Has taken aripiprazole in the last month or has experienced adverse effects from it at
             any time in the past