Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Naltrexone; Placebo
Intervention description: Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7); Placebo for 7 days matched to Naltrexone
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol dependence; Alcoholism; Craving; Genetic

Summary:

      The purpose of this study is to determine whether naltrexone (an opiate blocking agent
      approved for the treatment of alcohol dependence) is more effective in the reduction of
      alcohol craving and drinking compared to placebo in individuals with particular genetic
      predisposition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Age 21-65. 2. Meets the DSM IV criterion for current alcohol dependence including
             "loss of control over drinking" (criterion 4) but does not necessarily have signs of
             physiologic dependence as expressed in criterion for tolerance development (criterion
             1) and withdrawal symptoms or use to avoid withdrawal symptoms (criterion 2).

             3. Drinks hard liquor/spirits and does not have aversion to this form of alcohol.

             4. Drinks alone (not in the presence of others) some of the time (to maximize the
             potential of drinking in the bar lab where a subject will not be in the company of
             others).

             5. Currently is not engaged in, and does not want treatment for, alcohol related
             problems.

             6. Able to read and understand questionnaires and informed consent. 7. Lives within 50
             miles of the study site. 8. Able to maintain abstinence for two days (without the aid
             of detox medications) as determined by self-report and breathalyzer measurements.

        Inclusion for fMRI imaging sub-study (see methodology section for rationale):

          1. Does not have metal objects in the head/neck.

          2. Does not have a history of claustrophobia leading to significant clinical anxiety
             symptoms.

        Exclusion Criteria:

          -  1. Currently meets DSM-IV criteria for any other psychoactive substance dependence
             disorder.

             2. History of opiate abuse or a positive urine drug screen for opiates. 3. Any
             psychoactive substance use (except marijuana and nicotine) within the last 30 days as
             evidenced by self-report and urine drug screen. For marijuana - no use within the last
             seven days.

             4. Meets DSM-IV criteria for current axis I disorders of major depression, panic
             disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar
             affective disorder, schizophrenia, dissociative disorders and eating disorders, any
             other psychotic disorder or an organic mental disorder.

             5. Has current suicidal ideation or homicidal ideation. 6. Need for maintenance or
             acute treatment with any psychoactive medication including anti-seizure medications.

             7. Current use of disulfiram, naltrexone, or acamprosate. 8. Clinically significant
             medical problems such as, cardiovascular, renal, gastrointestinal, or endocrine
             problems that would impair participation or limit medication ingestion.

             9. Past history of alcohol related medical illness such as gastrointestinal bleeding,
             pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.

             10. Hepatocellular disease indicated by elevations of SGPT Alanine transaminase(ALT)
             or SGOT Aspartate transaminase(AST) greater than 3 times normal at screening.

             11. Females of child-bearing potential who are pregnant (by urine HCG), nursing, or
             who are 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.