Phase 2
N=150
ABT-436 for Alcohol Dependence
Alcohol Dependence · Alcohol Abuse · Alcohol Use Disorders · Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT01613014 ↗Enrolled (actual)
150
Serious AEs
2.1%
Results posted
Apr 2017
Primary outcome: Primary: Weekly Percentage of Heaving Drinking Days — 37.6; 31.3 weekly percentage of heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ABT-436 (Drug); Matched Placebo - Sugar Pill (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weekly Percentage of Heaving Drinking Days |
37.6; 31.3 | — |
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:
- 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 ( 100 bpm or QTc interval corrected for heart rate using the Fridericia formula (QTcF) > 450 msec.
- Have HIV or Hepatitis A, B or C.
Data sourced from ClinicalTrials.gov (NCT01613014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.