CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 enrolled
Drug / intervention
gabapentin 600 mg +5 moredrug
Likely dose
gabapentin 600 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.

Search/NCT05319756
NCT05319756Phase 4Completed

A Phase 4 Randomized Double-blind Double-dummy Placebo & Active-controlled Single-dose Six-way Crossover Study Evaluating Abuse Potential of NEURONTIN® Taken Orally With Oxycodone HCL in Healthy Non-drug Dependent Recreational Opioid Users

Viatris Specialty LLC·interventional·Posted Apr 8, 2022·Updated Aug 14, 2023

In Brief

A Phase 4 clinical trial evaluating gabapentin 600 mg, gabapentin 1200 mg, and 4 other interventions for Abuse Potential. Completed, enrolled 54 participants across 1 site.

Detailed Summary

This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6 treatment, 6-period crossover single-dose, Williams square design study in healthy male and/or female adult, non-drug-dependent recreational opioid users.

Study Details

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

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedApr 8, 2022
Enrollment StartApr 30, 2021
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.2 years ago

Interventions

gabapentin 600 mgdrug

Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

gabapentin 1200 mgdrug

Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

gabapentin 600 mg and oxycodone HCl 20 mgdrug

Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg

gabapentin 1200 mg and oxycodone HCl 20 mgdrug

Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

oxycodone HCl 20 mgdrug

Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin

placebodrug

Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl