MedTrace Logo

Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users

NCT05053126 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Abuse Potential

Interventions

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

Sponsors & Collaborators

  • Viatris Specialty LLC

    lead INDUSTRY

Principal Investigators

  • Dik WH Ng, PhD · Mylan Pharmaceutials

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2022-04-01
Completion
2022-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053126 on ClinicalTrials.gov