Trials / Completed
CompletedNCT06097676
An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users
A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Arbor Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.
Detailed description
The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil immediate-release (GE-IR), the active moiety in Horizant in comparison to placebo and an active control with known abuse potential (i.e., alprazolam). This study will be a randomized, double-blind, active- and placebo-controlled, 5-way crossover study to determine the abuse potential of gabapentin enacarbil immediate release (GE-IR) relative to alprazolam (active control) and placebo, in nondependent, recreational drug users with sedative drug use experience. This study will consist of 3 phases: screening, qualification, and treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo |
| DRUG | Alprazolam 2 mg | Oral dose of alprazolam 2 mg |
| DRUG | Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg | Oral dose of GE-IR 200 mg |
| DRUG | Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg | Oral dose of GE-IR 450 mg |
| DRUG | Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg | Oral dose of GE-IR 700 mg |
Timeline
- Start date
- 2021-09-28
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2023-10-24
- Last updated
- 2024-08-12
- Results posted
- 2024-01-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06097676. Inclusion in this directory is not an endorsement.