ABT-436 for Alcohol Dependence

NCT01613014 | Completed Phase 2 Results DMC

• 1 other identifier: NCIG-004
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Alcohol Dependence; Alcohol Abuse; Alcohol Use Disorders; Alcoholism

Keywords

Alcohol; Alcohol Dependence; Alcohol Abuse; Alcohol Use Disorders; Alcoholism

Outcome Measures

Primary Outcomes (1)

• Weekly Percentage of Heaving Drinking Days

  The primary objective of this study is to assess the efficacy of ABT-436 to reduce the weekly percentage of heavy drinking days (reduction in drinking) in subjects with alcohol dependence confirmed by DSM-IV-TR criteria. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. The outcome measure was averaged across weeks 2-12.

  Weeks 2-12

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Matched Placebo sugar pill - target dose 2 pills BID

Drug: Matched Placebo - Sugar Pill

ABT-436

ACTIVE COMPARATOR

ABT-436 Target dose of 400 mg BID

Drug: ABT-436

Interventions

ABT-436 DRUG

Target dose - 400mg BID

ABT-436

Matched Placebo - Sugar Pill DRUG

Target Dose - 2 pills BID

Sugar Pill

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead
• AbbVie: collaborator

Study Sites (5)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston Medical Center

Quincy, Massachusetts, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Virginia

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Megan Ryan, Clinical Program Director
• Organization: NIAAA

mryan1@mail.nih.gov

3014434225

Study Officials

• Raye Litten, PhD

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: February 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

US (5)