At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 110 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Oxycodone 20 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.
Randomized, Double-blind, Active & Placebo-controlled, 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy, Nondependent, Recreational Opioid Users
In Brief
A Phase 4 clinical trial evaluating Placebo, Oxycodone 20 mg, and 2 other interventions for Abuse Potential. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbuse Potential
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
Enrollment StartJan 2022
Primary CompletionApr 2023
First PostedFeb 2024
TodayJul 2026
First PostedFeb 8, 2024
Enrollment StartJan 31, 2022
Primary CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.4 years ago
Interventions
Placebodrug
Participant will receive oral dose of placebo.
Oxycodone 20 mgdrug
Participant will receive oral dose of oxycodone 20 mg.
GE-IR 200 mgdrug
Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.
GE-IR 450 mgdrug
Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.