NCT02252536

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

November 14, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

September 26, 2014

Results QC Date

April 9, 2018

Last Update Submit

October 15, 2018

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorderalcoholismalcohol dependencedrinking alcohol

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With no Heavy Drinking Days (PSNHDD)

    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).

    Weeks 22-25

Secondary Outcomes (13)

  • 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

  • Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels

    Weeks 22-25

  • Percentage of Days Abstinent Per Week

    Weeks 22-25

  • Percentage of Heavy Drinking Days Per Week

    Weeks 22-25

  • +8 more secondary outcomes

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Matching placebo, sugar pill

Drug: Placebo

Gabapentin Enacarbil

ACTIVE COMPARATOR

600 mg Gabapentin Enacarbil (Horizant)

Drug: gabapentin enacarbil

Interventions

gabapentin enacarbilDRUG

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

Also known as: Horizant Extended Release Tablets
Gabapentin Enacarbil
PlaceboDRUG

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

Sugar Pill

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Evaluations will be conducted in clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of California Los Angeles

Los Angeles, California, United States

Location

Friends Research Institute

San Francisco, California, 94103, United States

Location

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai St. Luke's Hospital

New York, New York, 10025, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

University of Virginia

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Conditions

AlcoholismAlcohol Drinking

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Results Point of Contact

Title
Megan Ryan
Organization
NIAAA
mryan1@mail.nih.gov
3014434225

Study Officials

  • Raye Z. Litten, Ph.D.

    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 14, 2018

Results First Posted

September 21, 2018

Record last verified: 2018-10

Locations

US(10)