NCT05053126

Study Evaluating Abuse Potential of Lyrica® 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 the Abuse Potential of Lyrica® Taken Orally With Oxycodone HCL in Healthy Non-Drug Dependent Recreational Opioid Users

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Viatris Specialty LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 4 clinical study in healthy non-drug dependent recreational opioid users to assess the abuse potential of Lyrica when taken alone or in combination with oxycodone.

Detailed description

This is a randomized, double-blind, double-dummy, placebo- and active-controlled, 6-treatment, 6-period crossover, single-dose study in healthy male and/or female adult, non drug-dependent recreational opioid users. The study includes Screening, a Qualification Phase, a Treatment Phase and Follow-up. This study will randomize approximately 60 adult male and female (at least 20% female) participants (10 participants in each sequence) in the Treatment Phase to ensure at least 48 participants complete the Treatment Phase of the study. There will be 8 visits to the clinic in total and a follow-up telephone call at the end of the study. The duration of participation will be approximately 16 weeks and 7 of the visits will involve clinic stays of 4 days/3 nights.

Conditions

• Abuse Potential

Interventions

Type	Name	Description
DRUG	Pregabalin 300mg	Participant will receive an oral dose of pregabalin 300 mg
DRUG	pregabalin 450 mg	Participant will receive an oral dose of pregabalin 450 mg
DRUG	Pregabalin 300 mg with oxycodone 20 mg	Participant will receive an oral dose of pregabalin 300 mg and oxycodone 20 mg
DRUG	pregabalin 450 mg with oxycodone 20 mg	Participant will receive an oral dose of pregabalin 450 mg and oxycodone 20 mg
DRUG	oxycodone 20 mg	Participant will receive an oral dose of oxycodone 20 mg
DRUG	Placebo	Participant will receive an oral dose of placebo

Timeline

• Start date: 2021-07-27
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-09-22
• Last updated: 2023-08-14
• Results posted: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study