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A Phase 2, Double-Blind, Randomized, Placebo Controlled Trial to Assess the Efficacy of ABT-436 for Alcohol Dependence

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Trial Conditions
  • Alcohol Dependence
  • Alcohol Abuse
  • Alcohol Use Disorders
  • Alcoholism
What is the purpose of this trial?

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.

Date & Status

Not yet recruiting

Who can Participate?

Eligibility

Ages:
21  - 65 

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Raye Litten, PhD
Trial Interventions
Drug
  • ABT-436
  • Matched Placebo - Sugar Pill
Physician Researcher

Investigator Name:

  • Raye Litten, PhD

Other Information

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase: Phase 2
Trial ID: NCT01613014
Volunteers:  Not Accepting Healthy Volunteers

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