CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
gabapentin 600 mg +4 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/NCT04570436
NCT04570436Phase 4Completed

A Phase 4, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Single-dose, Five-way Crossover Study Evaluating the Abuse Potential of Three Doses of NEURONTIN® Taken Orally in Healthy, Non-drug Dependent Participants With Sedative Drug Abuse Experience

Viatris Specialty LLC·interventional·Posted Sep 30, 2020·Updated Jul 24, 2024

In Brief

A Phase 4 clinical trial evaluating gabapentin 600 mg, gabapentin 1200 mg, and 3 other interventions for Abuse Potential. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.

Study Details

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

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedSep 30, 2020
Enrollment StartMar 29, 2021
Primary CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.8 years ago

Interventions

gabapentin 600 mgdrug

participants will receive an oral dose of gabapentin 600 mg

gabapentin 1200 mgdrug

participants will receive an oral dose of gabapentin 1200 mg

gabapentin 1800 mgdrug

participants will receive an oral dose of gabapentin 1800 mg

diazepam 20 mgdrug

participants will receive an oral dose of 20 mg dose of diazepam

placeboother

participants will receive an oral dose of placebo