NCT05319756

Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Viatris Specialty LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful completion of the Qualification Phase the participants will be enrolled in the Treatment phase. The Treatment Phase is a randomized, double-blind, double dummy, placebo- and active controlled, 6 treatment, 10-sequence, 6 period crossover, single-dose, Williams square design study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of each of the Treatment Phase 6 periods, which will be separated by a washout of at least 14 days, participants will receive an oral dose of either gabapentin 600 mg or 1200 mg alone, or concomitantly with a 20 mg dose of oxycodone HCl or 20 mg monotherapy of oxycodone HCl or a placebo. Study treatments will be administered under fasted conditions (overnight fast and no food until 4 hours after dosing). Water will be allowed without restriction until 1 hour prior to dosing and 1 hour after dosing.

Conditions

• Abuse Potential

Interventions

Type	Name	Description
DRUG	gabapentin 600 mg	Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl
DRUG	gabapentin 1200 mg	Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl
DRUG	gabapentin 600 mg and oxycodone HCl 20 mg	Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg
DRUG	gabapentin 1200 mg and oxycodone HCl 20 mg	Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg
DRUG	oxycodone HCl 20 mg	Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin
DRUG	placebo	Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl

Timeline

• Start date: 2021-04-30
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2022-04-08
• Last updated: 2023-08-14
• Results posted: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study