Understanding Treatment Response With Naltrexone Among White Alcoholics
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Placebo Oral Tablet; Naltrexone
Intervention description: Placebo pill; 50 mg of naltrexone prior to challenge session
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Groups 1 and 3 get placebo in session 1 and placebo in session 2, Groups 2 and 4 get placebo in session 1 and naltrexone in session 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: Male
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This is a study involving treatment for alcohol dependence among males of European or Asian
      decent. The ultimate aim of this line of investigation is to further establish a genetic link
      between alcohol dependence and treatment by defining an endophenotype associated with
      treatment response. The study consists of two inpatient alcohol challenge sessions with
      treatment using random assignment to either naltrexone or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males 21 years of age or older of European or Asian decent.

          2. Has a current DSM IV diagnosis of alcohol dependence as determined by the Structural
             Clinical Interview for DSM IV (SCID-IV Mini).

          3. Drank an average of 21 drinks/week in the 60 days prior to treatment and had at least
             2 occasions of heavy drinking (5 or more drinks on a given day for men), as measured
             by the Timeline Followback (TLFB).

          4. Has adequate vision, hearing, and ability to communicate to allow study participation.

          5. Successfully completes detoxification as manifested by at least 48 consecutive hours
             of no self-reported alcohol use immediately prior to admission to the inpatient unit.

          6. Has signed a witnessed informed consent

          7. Scores below an 8 on the Clinical Inventory of Withdrawal for Alcohol (CIWA) prior to
             starting naltrexone/placebo; and 8) Can speak, print, and understand English.

        Exclusion Criteria:

          1. Meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine
             in the last 6 months.

          2. Tests positive on the urine drug screen for opioids, cocaine, or amphetamine at the
             screening visit (only 1 repeat test permitted).

          3. Meets current or lifetime DSM-IV criteria for bipolar affective disorder,
             schizophrenia, or any psychotic disorder

          4. The presence of unstable or serious medical illness, including history of stroke,
             seizure disorder, severe liver disease (AST or ALT > 5x normal at the time of
             randomization), or unstable cardiac disease

          5. Has taken any psychotropic medications (including disulfiram) regularly within the
             last seven days prior to randomization (14 days for fluoxetine) or needs immediate
             treatment with a psychotropic medication (with the exception of detoxification
             medications or benadryl used sparingly for sleep)

          6. Over age 64 and has evidence of severe cognitive impairment as evidenced by a
             Mini-mental status exam (MMSE) score <24

          7. Has suicidal or homicidal ideation necessitating inpatient hospitalization

          8. Has been abstinent more than 14 days prior to Phase 1

          9. Is of African Descent

         10. Meets current DSM-IV criteria for for major depression (non-substance induced), PTSD,
             or panic disorder.

         11. Has significant hematological, pulmonary, endocrine, cardiovascular, renal, or
             gastrointestinal disease.