Clinical trial NCT02252536: HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: alcohol use disorder
alcoholism
alcohol dependence
drinking alcohol
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
Collaborators: name: Arbor Pharmaceuticals, Inc.
First posted: 2014-09-30
Enrollment: 346
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With no Heavy Drinking Days (PSNHDD)
timeFrame: Weeks 22-25
Secondary outcomes:
measure: Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint)
timeFrame: Weeks 22-25
measure: Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level
timeFrame: Weeks 22-25
measure: Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels
timeFrame: Weeks 22-25
measure: Percentage of Days Abstinent Per Week
timeFrame: Weeks 22-25
measure: Percentage of Heavy Drinking Days Per Week
timeFrame: Weeks 22-25
measure: Weekly Mean Number of Drinks Per Week
timeFrame: Weeks 22-25
measure: Weekly Mean Drinks Per Drinking Day
timeFrame: Weeks 22-25
measure: Cigarettes Per Week Among Smokers
timeFrame: Weeks 22-25
measure: Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)]
timeFrame: Weeks 24 and 26
measure: Alcohol Related Consequences (ImBIBe) Score
timeFrame: Weeks 24 and 26
measure: Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Week 26
measure: Beck Anxiety Inventory (BAI) Score
timeFrame: Week 26
measure: Beck Depression Inventory - II
timeFrame: Week 26
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Francisco
country: United States
facility: Friends Research Institute
state: California
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Mount Sinai St. Luke's Hospital
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Raye Z. Litten, Ph.D.
role: STUDY_CHAIR
References: