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
Therapeutic Area: Other
Phase: Phase II
Enrolling Sites: University of Miami Medical Group
Enrolling Since: 5/1/2015
The purpose of this study is to determine whether gabapentin enacarbil is effective in the
treatment of problems with alcohol.
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.
Evaluations will be conducted in clinic.
Minimum Age: 21 Years
Maximum Age: N/A
Accepts healthy volunteers: No
Scott Hyman, Scientist, SOM
(305) 243 1301