ABT-436 for Alcohol Dependence

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Dependence, Alcohol Abuse, Alcohol Use Disorders, Alcoholism

In brief

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.

Key facts

Study ID

NCT01613014

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

150

Starts

2013-02-01

Expected to finish

2015-07-01

Last updated by the study team

2017-04-04

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Current, past, or lifetime diagnosis of psychotic disorders (note schizophrenia is diagnosed under the psychotic disorder module of the MINI)
• Current or past diagnosis of bipolar disorder,
• Current or past year major depressive episode,
• Current (past 3 months) eating disorder (anorexia or bulimia), or
• Current (within past year) diagnosis of panic disorder with or without agoraphobia,
• 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.

Where it is running

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Boston Medical Center — Quincy, Massachusetts, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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