CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Pregabalin 300mg +5 moredrug
Likely dose
Pregabalin 300mgfrom 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.

Search/NCT05053126
NCT05053126Phase 4Completed

A Phase 4 Randomized Double-Blind Double-Dummy Placebo & Active-Controlled Single-Dose Six-Way Crossover Study Evaluating the Abuse Potential of Lyrica® Taken Orally With Oxycodone HCL in Healthy Non-Drug Dependent Recreational Opioid Users

Viatris Specialty LLC·interventional·Posted Sep 22, 2021·Updated Aug 14, 2023

In Brief

A Phase 4 clinical trial evaluating Pregabalin 300mg, pregabalin 450 mg, and 4 other interventions for Abuse Potential. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This is a Phase 4 clinical study in healthy non-drug dependent recreational opioid users to assess the abuse potential of Lyrica when taken alone or in combination with oxycodone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbuse Potential
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedSep 22, 2021
Enrollment StartJul 27, 2021
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.8 years ago

Interventions

Pregabalin 300mgdrug

Participant will receive an oral dose of pregabalin 300 mg

pregabalin 450 mgdrug

Participant will receive an oral dose of pregabalin 450 mg

Pregabalin 300 mg with oxycodone 20 mgdrug

Participant will receive an oral dose of pregabalin 300 mg and oxycodone 20 mg

pregabalin 450 mg with oxycodone 20 mgdrug

Participant will receive an oral dose of pregabalin 450 mg and oxycodone 20 mg

oxycodone 20 mgdrug

Participant will receive an oral dose of oxycodone 20 mg

Placebodrug

Participant will receive an oral dose of placebo