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Opioid Partial Agonist

Buprenorphine Continuation for Opioid Use Disorder

Phase 4

Waitlist Available

Led By Aurora Quaye, MD

Research Sponsored by Aurora Quaye

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 48 hours after surgery

Awards & highlights

Study Summary

This trial is investigating whether it is better to continue taking a low dose of buprenorphine or to discontinue it entirely before surgery, in order to manage postoperative pain without interrupting treatment for opioid use disorder.

Who is the study for?

This trial is for adults with Opioid Use Disorder who have been on buprenorphine (12mg or more) for at least a month. They must be in good health according to the American Society of Anesthesia standards and scheduled for surgery expected to cause moderate pain post-op. Pregnant individuals, those unable to consent, or with major illnesses like advanced cancer or severe organ disease can't participate.Check my eligibility

What is being tested?

The study tests if continuing low doses of buprenorphine (8mg) during surgery is better than full doses for managing pain without disrupting treatment for opioid addiction. It compares these two approaches in patients undergoing elective surgeries.See study design

What are the potential side effects?

Potential side effects may include inadequate pain control which could lead to needing higher doses of opioids. The exact side effects will depend on how each individual responds to either continuation strategy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-operative pain scores: 24 hours after surgery

Post-operative pain scores: 48 hours after surgery

Post-operative pain scores: 72 hours after surgery

Secondary outcome measures

Opioid Cravings

Opioid Misuse

Opioid Relapse

+3 more

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167

17%

Nausea

Constipation

Vomiting

Headache

Dizziness

Somnolence

Drug withdrawal syndrome

100%

80%

60%

40%

20%

Study treatment Arm

OL Buprenorphine HCl Buccal Film

DB Buprenorphine HCl Buccal Film

DB Placebo Film

Trial Design

2Treatment groups

Experimental Treatment

Group I: Buprenorphine Full Dose ContinuationExperimental Treatment1 Intervention

Patients instructed to continue taking the full prescribed dose of buprenorphine.

Group II: Buprenorphine Dose ReductionExperimental Treatment1 Intervention

Patients instructed to reduce buprenorphine to 8mg prior to surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buprenorphine

2014

Completed Phase 4

~2600

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aurora QuayeLead Sponsor

MaineHealthOTHER

71 Previous Clinical Trials

49,295 Total Patients Enrolled

Aurora Quaye, MDPrincipal InvestigatorMaine Medical Center; Spectrum Healthcare Partners

1 Previous Clinical Trials

76 Total Patients Enrolled

Media Library

Buprenorphine (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04981678 — Phase 4

Opioid Use Disorder Research Study Groups: Buprenorphine Dose Reduction, Buprenorphine Full Dose Continuation

Opioid Use Disorder Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT04981678 — Phase 4

Buprenorphine (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04981678 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other experimental procedures similar to this one?

"At the moment, 45 different clinical trials are underway to further investigate this treatment. Of those 45 active trials, 12 have reached Phase 3. However, the many trials for this treatment are not limited to Durham, North carolina and can be found in 229 locations."

Answered by AI

What are the key aims of this investigation?

"The main objective of this clinical trial is to assess post-operative pain scores 48 hours after surgery. Secondary objectives include measuring instances of opioid use and withdrawal, as well as opioid cravings, over a 30-day period."

Answered by AI

Are people with specific medical conditions currently being sought for this research?

"That is correct. The latest information available on clinicaltrials.gov affirms that this particular trial is still looking for patients. This trial was created on 1/1/2022 and was last edited on 4/6/2022. Only 1 location is enrolling a total of 80 patients."

Answered by AI

How many people fit the profile to be included in this experiment?

"Yes, this is accurate. The clinical trial in question was originally posted on January 1st, 2022 and was updated most recently on April 6th, 2022. They are looking for 80 patients from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

Aurora Quaye 2022. "The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04981678.