At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 86 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
Alprazolam 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Placebo, Alprazolam 2 mg, and 3 other interventions for Abuse Potential. Completed, enrolled 86 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbuse Potential
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
Enrollment StartSep 2021
Primary CompletionJun 2022
First PostedOct 2023
TodayJul 2026
First PostedOct 24, 2023
Enrollment StartSep 28, 2021
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.7 years ago
Interventions
Placebodrug
Placebo
Alprazolam 2 mgdrug
Oral dose of alprazolam 2 mg
Gabapentin Enacarbil Immediate Release (GE-IR) 200 mgdrug
Oral dose of GE-IR 200 mg
Gabapentin Enacarbil Immediate Release (GE-IR) 450 mgdrug
Oral dose of GE-IR 450 mg
Gabapentin Enacarbil Immediate Release (GE-IR) 700 mgdrug
Oral dose of GE-IR 700 mg