NCT06247488

Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users

Randomized, Double-blind, Active & Placebo-controlled, 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy, Nondependent, Recreational Opioid Users

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Arbor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.

Detailed description

The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil immediate-release (GE-IR), the active moiety in Horizant, taken alone and taken in combination with oxycodone, compared to that of oxycodone alone. This study is a randomized, double-blind, active- and placebo-controlled, 6-way crossover design, aimed to assess the abuse potential, safety, and pharmacokinetics (PK) of GE-IR doses when administered alone or in combination with an opioid active control (oxycodone), and compared to placebo and oxycodone intake alone, in healthy, nondependent, recreational opioid users.

Conditions

• Abuse Potential

Interventions

Type	Name	Description
DRUG	Placebo	Participant will receive oral dose of placebo.
DRUG	Oxycodone 20 mg	Participant will receive oral dose of oxycodone 20 mg.
DRUG	GE-IR 200 mg	Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.
DRUG	GE-IR 450 mg	Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.

Timeline

• Start date: 2022-01-31
• Primary completion: 2023-04-25
• Completion: 2023-04-25
• First posted: 2024-02-08
• Last updated: 2024-08-12
• Results posted: 2024-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study