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

NCT02252536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2018-11-14

Study results available
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Summary

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

Conditions

Interventions

DRUG

gabapentin enacarbil

Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day

DRUG

Placebo

Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day

Sponsors & Collaborators

  • Arbor Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Raye Z. Litten, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252536 on ClinicalTrials.gov