← Back to Search

Opioid Analgesic

pregabalin 450 mg with oxycodone 20 mg for Substance Abuse

Phase 4
Waitlist Available
Research Sponsored by UpJohn US 1 LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours after treatment
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).
Secondary outcome measures
Bipolar VAS for "Overall Drug Liking"
Bipolar VAS for "Take Drug Again"
Unipolar VAS for "Any Drug Effect"
+1 more

Side effects data

From 2022 Phase 4 trial • 60 Patients • NCT05053126
5%
Vomiting
3%
Nausea
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lyrica 300mg With Oxycodone 20 mg
Lyrica 450 mg With Oxycodone 20 mg
Lyrica 450 mg
Lyrica 300 mg
Placebo
Oxycodone 20 mg

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Lyrica 450 mg with Oxycodone 20 mgExperimental Treatment1 Intervention
Single Dose
Group II: Lyrica 450 mgExperimental Treatment1 Intervention
Single Dose
Group III: Lyrica 300mg with Oxycodone 20 mgExperimental Treatment1 Intervention
Single Dose
Group IV: Lyrica 300 mgExperimental Treatment1 Intervention
Single Dose
Group V: Oxycodone 20 mgActive Control1 Intervention
Single Dose
Group VI: PlaceboPlacebo Group1 Intervention
Single Dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin 300 mg with oxycodone 20 mg
2021
Completed Phase 4
~60
pregabalin 450 mg with oxycodone 20 mg
2021
Completed Phase 4
~60
Pregabalin 300mg
2019
Completed Phase 4
~310
pregabalin 450 mg
2021
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

UpJohn US 1 LLCLead Sponsor
Viatris Specialty LLCLead Sponsor
2 Previous Clinical Trials
106 Total Patients Enrolled
Dik WH Ng, PhDStudy DirectorMylan Pharmaceutials
2 Previous Clinical Trials
1,386 Total Patients Enrolled
~15 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top