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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)10 sites in 1 country346 target enrollmentJune 2015

ConditionsAlcohol Use Disorder

InterventionsPlacebo gabapentin enacarbil

Drugsgabapentin enacarbil Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Alcohol Use Disorder
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Enrollment: 346
Locations: 10
Primary Endpoint: Percentage of Subjects With no Heavy Drinking Days (PSNHDD)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

March 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•Evaluations will be conducted in clinic.

Arms & Interventions

Sugar Pill

Matching placebo, sugar pill

Intervention: Placebo

Gabapentin Enacarbil

600 mg Gabapentin Enacarbil (Horizant)

Intervention: gabapentin enacarbil

Outcomes

Primary Outcomes

Percentage of Subjects With no Heavy Drinking Days (PSNHDD)

Time Frame: Weeks 22-25

The primary objective of the study is to compare the efficacy of HORIZANT (gabapentin enacarbil) Extended-Release Tablets 600 mg twice daily (BID) with matched placebo on the primary alcohol consumption outcome endpoint, percentage of subjects with no heavy drinking days (PSNHDD) during the last 4 weeks of treatment, among patients with Alcohol Use Disorder (AUD).

Secondary Outcomes

Percentage of Days Abstinent Per Week(Weeks 22-25)
Weekly Mean Drinks Per Drinking Day(Weeks 22-25)
Cigarettes Per Week Among Smokers(Weeks 22-25)
Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)](Weeks 24 and 26)
Pittsburgh Sleep Quality Index (PSQI) Score(Week 26)
Percentage of Heavy Drinking Days Per Week(Weeks 22-25)
Weekly Mean Number of Drinks Per Week(Weeks 22-25)
Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint)(Weeks 22-25)
Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level(Weeks 22-25)
Alcohol Related Consequences (ImBIBe) Score(Weeks 24 and 26)
Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels(Weeks 22-25)
Beck Anxiety Inventory (BAI) Score(Week 26)
Beck Depression Inventory - II(Week 26)