Medication Development in Alcoholism: Acamprosate Versus Naltrexone
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Acamprosate; Naltrexone; Placebo
Intervention description: Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration; 50mg capsule, Once daily, 1 week duration; Matched placebo capsule, 1 week duration
Intervention MeSH terms: Naltrexone; Acamprosate
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to develop and validate a human laboratory model for prediction
      of medication efficacy in clinical trials for relapse prevention in alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ≥ 18 and ≤ 55 years of age

          -  Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current
             alcohol dependence

          -  Does not desire treatment

          -  Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute
             Withdrawal Assessment (CIWA) ≤ 8, at the time of testing, with no evidence of drinking
             for at least 3 days but no more than 7 days prior to the cue reactivity session

          -  Able to complete and understand questionnaires and study procedures in English

          -  Verbal I.Q. estimate ≥ 85

          -  Signed informed consent

        Exclusion Criteria:

          -  Currently meets DSM-IV criteria for dependence on substances other than alcohol or
             nicotine

          -  Significant medical disorders that will increase potential risk or interfere with
             study participation

          -  Sexually active women with childbearing potential who are pregnant, nursing, or refuse
             to use a reliable method of birth control

          -  Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety
             disorders

          -  Treatment within the month prior to screening with investigational medications or
             those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone
             (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents

          -  Chronic treatment with any narcotic-containing medications during the previous month
             or evidence of current opiate use

          -  Liver function tests more than three times normal or elevated bilirubin

          -  No fixed domicile and/or no availability by telephone or beeper

          -  Current involvement in or plans for treatment prior to study completion

          -  Patients who have a history of adverse drug reactions to the study drugs or their
             ingredients

          -  Failure to take double-blind medication as prescribed

          -  Inability to understand or comply with the provisions of the protocol or consent form