Status:
COMPLETED
HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsors:
Arbor Pharmaceuticals, Inc.
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.
Eligibility Criteria
Inclusion
- Subjects must meet each one of the following inclusion criteria in order to be eligible for participation in the study:
- Be at least 21 years of age.
- Have a current (past 12 months) DSM-5 diagnosis of AUD.
- 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).
- Be seeking treatment for problems with alcohol.
- Additional will be evaluated in clinic.
Exclusion
- Evaluations will be conducted in clinic.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT02252536
Start Date
June 1 2015
End Date
March 1 2017
Last Update
November 14 2018
Active Locations (10)
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1
University of California Los Angeles
Los Angeles, California, United States
2
Friends Research Institute
San Francisco, California, United States, 94103
3
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
4
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224