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

Investigator: Ihsan Salloum

Institutional Protocol #: 20150100

National Clinical Trials Identifier: NCT02252536

Funding Agency/Sponsor: National Institute on Alcohol Abuse and Alcoholism

Division: Psychiatry

Therapeutic Area: Other

Phase: Phase II

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 4/19/2017


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

Eligibility 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.

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Scott Hyman, Scientist, SOM
(305) 243 1301


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