Trial record 2 of 161 for:    Open Studies | "Alcoholism"

ABT-436 for Alcohol Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT01613014
First received: June 4, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Alcohol Abuse
Alcohol Use Disorders
Alcoholism
Drug: ABT-436
Drug: Matched Placebo - Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo Controlled Trial to Assess the Efficacy of ABT-436 for Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Reduction in the weekly percentage of heaving drinking days [ Time Frame: Weeks 2-12 ] [ Designated as safety issue: No ]
    The primary objective of this study is to assess the efficacy of ABT-436 to reduce the weekly percentage of heavy drinking days 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.


Estimated Enrollment: 148
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Matched Placebo sugar pill - target dose 2 pills BID
Drug: Matched Placebo - Sugar Pill
Target Dose - 2 pills BID
Active Comparator: ABT-436
ABT-436 Target dose of 400 mg BID
Drug: ABT-436
Target dose - 400mg BID

Detailed Description:

Adrenocorticotropic hormone (ACTH) release from the pituitary gland via V1B stimulation is central to the hypothalamus-pituitary-adrenal (HPA) axis stress response (Carrasco & Van de Kar-2003, Herman & Cullinan-1997, Sapolsky et al-2000; Tsigos & Chrousos-2002). Chronic dysregulation of the HPA axis is common in major depressive disorder, anxiety disorders, and substance abuse disorders characterized by elevated AVP, increased responsiveness to AVP, as well as either increased or decreased overall HPA axis activity or responsiveness (Dinan & Scott-2005). HPA axis normalization via pituitary V1B antagonism is a mechanism for potential ABT-436 efficacy in these disorders (Schüle et al-2009). Limbic V1B antagonism in the brain may also contribute to efficacy (Roper et al-2011).

Alcohol dependence, or alcoholism, is characterized by a chronic relapsing course, in which alcohol-associated cues and stress are known relapse triggers (Brownell et al-1986, Heilig & Egli-2006, Sinha & Li-2007). Recent research suggests that neural systems mediating behavioral stress responses may offer useful targets for pharmacotherapy of alcoholism. In animal models, excessive alcohol consumption that results from a history of alcohol dependence is accompanied by increased behavioral sensitivity to stress (Heilig & Koob-2007). Preclinical studies have shown that V1B antagonists can attenuate reinstatement of heroin and alcohol self-administration, and block dependence-induced exaggeration of alcohol intake, in rats. V1B antagonists have also been shown to block stress-induced reinstatement of drug and alcohol seeking in ethanol dependent rats (Zhou-2011). For these reasons the NIAAA Clinical Investigations Group (NCIG) proposes to test ABT-436 in a Phase 2, proof of concept trial for the treatment of alcohol dependence.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613014

Contacts
Contact: Megan Ryan, MBA mryan1@mail.nih.gov

Locations
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21224
Contact: Harrison, MS    410-550-1191      
Principal Investigator: Eric Strain, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Devine, PhD    617-638-7888      
Principal Investigator: Domenic Ciraulo, MD         
Boston Medical Center Recruiting
Quincy, Massachusetts, United States
Contact: Devine, PhD    617-638-7888      
Principal Investigator: Domenic Ciraulo, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mahoney, MS    215-322-2200      
Principal Investigator: Kyle Kampman, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Mendoza, BS         
Principal Investigator: Nassima Ait-Daoud, MD         
Sponsors and Collaborators
AbbVie
Investigators
Principal Investigator: Raye Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

No publications provided

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT01613014     History of Changes
Other Study ID Numbers: NCIG-004
Study First Received: June 4, 2012
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcohol
Alcohol Dependence
Alcohol Abuse
Alcohol Use Disorders
Alcoholism

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Drinking Behavior
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 21, 2014