Evaluation of Abuse Potential of HORIZANT Taken Alone and With Oxycodone in Healthy, Nondependent Recreational Opioid Users

Abuse Potential Clinical Trial

Official title:
A Randomized, Double-blind, Active- and Placebo-controlled, 6-way Crossover Study to Evaluate the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules Taken Alone and in Combination With Oxycodone in Healthy, Nondependent, Recreational Opioid Users

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Abuse Potential

Clinical Trial Details

NCT number	NCT06247488
Study type	Interventional
Source	Azurity Pharmaceuticals
Contact
Status	Completed
Phase	Phase 4
Start date	January 31, 2022
Completion date	April 25, 2023

View Details

See also
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Completed	`NCT05319756` - Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users	Phase 4