Phase 2
Completed N=346
HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
Source: ClinicalTrials.gov NCT02252536 ↗Enrolled (actual)
346
Serious AEs
4.1%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Subjects With no Heavy Drinking Days (PSNHDD) — 17.3; 24.1 percentage of subjects with NHDD
Summary
The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With no Heavy Drinking Days (PSNHDD) |
17.3; 24.1 | — |
| SECONDARY Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint) |
16; 17 | — |
| SECONDARY Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level |
107; 115 | — |
| SECONDARY Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels |
69; 80 | — |
| SECONDARY Percentage of Days Abstinent Per Week |
49; 49.3 | — |
| SECONDARY Percentage of Heavy Drinking Days Per Week |
46.5; 43.1 | — |
| SECONDARY Weekly Mean Number of Drinks Per Week |
21.4; 23.1 | — |
| SECONDARY Weekly Mean Drinks Per Drinking Day |
3.9; 4.1 | — |
| SECONDARY Cigarettes Per Week Among Smokers |
61.4; 71 | — |
| SECONDARY Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)] |
2.5; 2.5 | — |
| SECONDARY Alcohol Related Consequences (ImBIBe) Score |
8.3; 9.6 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) Score |
4.4; 4.9 | — |
| SECONDARY Beck Anxiety Inventory (BAI) Score |
3.3; 4.6 | — |
| SECONDARY Beck Depression Inventory - II |
5.2; 6.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02252536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.