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Pregabalin 75 mg for Opioid Use Disorder (OPIATE Trial)

Phase 3
Waitlist Available
Led By Andre Lamy, MD, MHSc
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first.
Awards & highlights

OPIATE Trial Summary

This study is evaluating whether pregabalin can reduce opioid consumption in patients undergoing on-pump cardiac surgery.

OPIATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~starting the second day after surgery and ending after 5 days or 3 days of negative tests.
This trial's timeline: 3 weeks for screening, Varies for treatment, and starting the second day after surgery and ending after 5 days or 3 days of negative tests. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative opioid consumption
Daily opioid consumption
Secondary outcome measures
Average postoperative pain
Cumulative consumption of antiemetic medications
Daily consumption of antiemetic medications
+8 more

OPIATE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pregabalin + Usual CareExperimental Treatment3 Interventions
300 mg pregabalin taken orally within 2 hours before surgery and 75 mg pregabalin taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
Group II: Placebo + Usual CarePlacebo Group3 Interventions
Placebo taken orally within 2 hours before surgery and placebo taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin
FDA approved

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
366 Previous Clinical Trials
300,888 Total Patients Enrolled
McMaster UniversityOTHER
879 Previous Clinical Trials
2,596,999 Total Patients Enrolled
Andre Lamy, MD, MHScPrincipal InvestigatorHamilton Health Sciences Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery
Andre Lamy 2021. "Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04517110.
~4 spots leftby Apr 2025
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