ABT-436 for Alcohol Dependence
Condition: Alcohol Dependence; Alcohol Abuse; Alcohol Use Disorders; Alcoholism
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: ABT-436; Matched Placebo - Sugar Pill
Intervention description: Target dose - 400mg BID; Target Dose - 2 pills BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol; Alcohol Dependence; Alcohol Abuse; Alcohol Use Disorders; Alcoholism

Summary:

      The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly
      percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to
      placebo. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more
      drinks per drinking day for men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 21 years of age and no more than 65 years of age.

          -  Have a current (past 12 months) DSM-IV-TR diagnosis of alcohol dependence.

          -  Be seeking treatment for alcohol dependence and desire a reduction or cessation of
             drinking.

        Exclusion Criteria:

          -  current (past 12 months) abuse or dependence on any psychoactive substance other than
             alcohol, caffeine and nicotine, including sedatives and hypnotics, as defined by
             DSM-IV-TR criteria.

          -  positive urine toxicology screen performed during screening or baseline.

          -  been hospitalized for alcohol intoxication delirium, alcohol withdrawal delirium,
             alcohol-induced persisting dementia or amnestic disorder, or have had an alcohol
             withdrawal seizure, alcohol-induced psychotic disorder with a primary diagnosis of
             alcohol dependence or a history of any seizure disorder.

          -  Have any of the following, based on DSM-IV-TR criteria as assessed using the MINI:

               1. Current, past, or lifetime diagnosis of psychotic disorders (note schizophrenia
                  is diagnosed under the psychotic disorder module of the MINI)

               2. Current or past diagnosis of bipolar disorder,

               3. Current or past year major depressive episode,

               4. Current (past 3 months) eating disorder (anorexia or bulimia), or

               5. Current (within past year) diagnosis of panic disorder with or without
                  agoraphobia,

               6. Anti-social personality disorder.

          -  Have any underlying medical condition that could exacerbate during trial participation
             causing hospitalization, surgery, and/or the need to use exclusionary medications to
             treat condition.

          -  Be pregnant or breast-feeding or have plans to become pregnant at any time during the
             study.

          -  Have a clinically significant abnormal laboratory value;

          -  Hemoglobin A1c value > 7%.

          -  Have a clinically significant ECG as determined by the investigator or abnormal ECG
             heart rate (<45 or > 100 bpm or QTc interval corrected for heart rate using the
             Fridericia formula (QTcF) > 450 msec.

          -  Have HIV or Hepatitis A, B or C.