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Opioid Agonist/Antagonist

Buprenorphine/Naloxone for Pain

Phase 4
Waitlist Available
Led By Yi Zhang, MD, PhD
Research Sponsored by Massachusetts General Hospital
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 through study completion, an average of 6 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial looks at whether buprenorphine/naloxone (bup/nx) can help manage postoperative pain in people who have developed a tolerance to opioids.

Eligible Conditions
  • Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of Hospital Stay
Postoperative Opioid Consumption
Postoperative Pain Scores

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Buprenorphine/NaloxoneActive Control1 Intervention
Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed.
Group II: Standard Medication RegimentActive Control1 Intervention
Subjects will take conventional intravenous or oral opioid management.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,222 Total Patients Enrolled
21 Trials studying Pain
1,884 Patients Enrolled for Pain
Yi Zhang, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
23 Total Patients Enrolled
~18 spots leftby Nov 2025