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
|