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HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder

This study has been completed.
Sponsor:
Collaborator:
XenoPort, Inc.
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT02252536
First received: September 26, 2014
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.

Condition Intervention Phase
Alcohol Use Disorder
Drug: gabapentin enacarbil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of subjects with no heavy drinking days (PSNHDD) [ Time Frame: Weeks 22-25 ]
    The primary objective of the study is to compare the efficacy of HORIZANT (gabapentin enacarbil) Extended-Release Tablets 600 mg twice daily (BID) with matched placebo on the primary alcohol consumption outcome endpoint, percentage of subjects with no heavy drinking days (PSNHDD) during the last 4 weeks of treatment, among patients with Alcohol Use Disorder (AUD).


Enrollment: 346
Study Start Date: June 2015
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Matching placebo, sugar pill
Drug: Placebo
Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day
Active Comparator: Gabapentin Enacarbil
600 mg Gabapentin Enacarbil (Horizant)
Drug: gabapentin enacarbil
Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Other Name: Horizant Extended Release Tablets

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet each one of the following inclusion criteria in order to be eligible for participation in the study:

  1. Be at least 21 years of age.
  2. Have a current (past 12 months) DSM-5 diagnosis of AUD.
  3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
  4. Be seeking treatment for problems with alcohol.

Additional will be evaluated in clinic.

Exclusion Criteria:

Evaluations will be conducted in clinic.

  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: NCT02252536

Locations
United States, California
University of California Los Angeles
Los Angeles and Santa Monica, California, United States
Friends Research Institute
San Francisco, California, United States, 94103
United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Mount Sinai St. Luke's Hospital
New York, New York, United States, 10025
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
XenoPort, Inc.
Investigators
Study Chair: Raye Z. Litten, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT02252536     History of Changes
Other Study ID Numbers: NCIG - 006
Study First Received: September 26, 2014
Last Updated: March 8, 2017

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
alcohol use disorder
alcoholism
alcohol dependence
drinking alcohol

Additional relevant MeSH terms:
Disease
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Ethanol
Gabapentin
gamma-Aminobutyric Acid
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents

ClinicalTrials.gov processed this record on March 22, 2017