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

Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Use Disorder

Intervention: gabapentin enacarbil (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official(s) and/or principal investigator(s):
Raye Z. Litten, Ph.D., Study Chair, Affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Overall contact:
Megan Ryan, M.B.A., Email: mryan1@mail.nih.gov

Summary

The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of subjects with no heavy drinking days (PSNHDD)

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Megan Ryan, M.B.A., Email: mryan1@mail.nih.gov

University of California Los Angeles, Los Angeles and Santa Monica, California, United States; Recruiting
Katy Lunny, BS, Phone: 310.206.6756, Email: katylunny@psych.ucla.edu
Matthew Workey, PhD, Phone: 310.794.0619, Ext: 240, Email: mworley@mednet.ucla.edu
Steve Shoptaw, Ph.D., Principal Investigator
Lara Ray, Ph.D., ABPP, Principal Investigator

California Pacific Medical Center, San Francisco, California 94103, United States; Recruiting
Kathleen Garrison, BS, Phone: 415-600-3126, Email: garrisk@cpmcri.org
Reshmi Pal, MPH, Phone: 415.600.1634, Email: palrx@cpmcri.org
John Mendelson, MD, Principal Investigator

University of Miami, Miller School of Medicine, Miami, Florida 33136, United States; Recruiting
Scott Hyman, Ph.D., Phone: 305.243.1301, Email: s.hyman@miami.edu
Ihsan Salloum, MD, MPH, DFAPA, Principal Investigator

Johns Hopkins University School of Medicine, Baltimore, Maryland 21224, United States; Recruiting
Jessica Harris, BA, Phone: 410-550-9494, Email: jharras2@jhmi.edu
Joseph Harrison, MS, Phone: 410.550.3073, Email: jaharris@jhmi.edu
Eric Strain, MD, Principal Investigator

Boston University Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Eric Devine, Ph.D., Phone: 617-638-7888, Email: eric.devine@bmc.org
Eric Devine, Ph.D., Principal Investigator

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Recruiting
Eric Riley, Phone: 603-271-5227, Email: eric.e.riley@dartmouth.edu
Alan Green, M.D., Principal Investigator

Mount Sinai St. Luke's Hospital, New York, New York 10025, United States; Not yet recruiting
Joann Gomez, BS, Phone: 212-523-2926, Email: jogomez@chpnet.org
Richard Rosenthal, MD, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Lauren Rodriguez, BA, Phone: 215-222-3200, Ext: 102, Email: lrod@mail.med.upenn.edu
Kyle Kampman, MD, Principal Investigator

The University of Texas Southwestern Medical Center, Dallas, Texas 75235, United States; Recruiting
Traci Holmes, BS, Phone: 214-645-6959, Email: traci.holmes@utsouthwestern.edu
Collette Bice, MS, Phone: 214.645.6967
Sherwood Brown, M.D., Ph.D., Principal Investigator

University of Virginia, Charlottesville, Virginia 22911, United States; Recruiting
Eva Jenkins-Mendoza, BS, Phone: 434-243-0562, Email: emj9c@hscmail.mcc.virginia.edu
Tracie Kostelac, Phone: 434.243.0563
Nassima Ait-Daoud Tiouririne, MD, Principal Investigator

Additional Information

Starting date: June 2015
Last updated: August 10, 2015

Page last updated: August 20, 2015

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