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Clinical Trials/NCT02252536
NCT02252536CompletedPhase 2

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 enrollmentStarted: June 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
346
Locations
10
Primary Endpoint
Percentage of Subjects With no Heavy Drinking Days (PSNHDD)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Placebo Comparator

Matching placebo, sugar pill

Intervention: Placebo (Drug)

Gabapentin Enacarbil

Active Comparator

600 mg Gabapentin Enacarbil (Horizant)

Intervention: gabapentin enacarbil (Drug)

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)

Investigators

Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (10)

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