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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: gabapentin enacarbil; Drug: Placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02252536

NCIG - 006

Details and patient eligibility

About

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

Enrollment: 346 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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346 participants in 2 patient groups, including a placebo group

Sugar Pill

Placebo Comparator group

Description:

Matching placebo, sugar pill

Treatment:

Drug: Placebo

Gabapentin Enacarbil

Active Comparator group

Description:

600 mg Gabapentin Enacarbil (Horizant)

Treatment:

Drug: gabapentin enacarbil