NCT04570436

Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Viatris Specialty LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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, 5 treatment, 10-sequence, 5 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 5 periods, which will be separated by a washout of at least 14 days, participants will receive an oral dose of either NEURONTIN® 1800 mg, 1200 mg or 600 mg or 20 mg diazepam, or 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 an oral dose of gabapentin 600 mg
DRUG	gabapentin 1200 mg	participants will receive an oral dose of gabapentin 1200 mg
DRUG	gabapentin 1800 mg	participants will receive an oral dose of gabapentin 1800 mg
DRUG	diazepam 20 mg	participants will receive an oral dose of 20 mg dose of diazepam
OTHER	placebo	participants will receive an oral dose of placebo

Timeline

• Start date: 2021-03-29
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2020-09-30
• Last updated: 2024-07-24
• Results posted: 2023-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study