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Behavioral Intervention
Opioid Taper Before Surgery for Arthritis
N/A
Recruiting
Led By Kevin R Riggs, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a reliable telephone number for contact
Currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until approximately 2 weeks after surgery
Awards & highlights
Study Summary
This trial tests a pharmacist-led opioid taper to help those on chronic opioids reduce dose before surgery. A pharmacist provides education and adjusts the taper as needed.
Who is the study for?
This trial is for people planning to have knee or hip replacement surgery in the next 4-8 weeks, who are currently on a stable opioid dose of 20-90 MME for at least three months. Participants must speak English and have a reliable phone number. Those using certain opioids like Buprenorphine or Methadone, long-acting or transdermal opioids cannot join.Check my eligibility
What is being tested?
The study is testing a pharmacist-led program to reduce opioid use before knee or hip surgery. It involves education about pain and opioids, creating an individual tapering plan, and weekly follow-ups by phone to adjust the plan as needed.See study design
What are the potential side effects?
While specific side effects aren't listed for this intervention, reducing opioid doses can lead to withdrawal symptoms such as anxiety, irritability, sleep disturbances, increased pain sensitivity and flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a working phone number.
Select...
I have been on a stable dose of 20-90 MME oral opioids for 3 months.
Select...
I am scheduled for knee or hip replacement surgery in the next 4-8 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment until approximately 2 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until approximately 2 weeks after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability
Secondary outcome measures
Perioperative Pain
Study Recruitment Rate
Study Retention Rate
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pharmacist-led opioid taper interventionExperimental Treatment1 Intervention
The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period. Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,573 Previous Clinical Trials
2,273,234 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,894 Total Patients Enrolled
Kevin R Riggs, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a working phone number.I am currently taking opioid medication that includes Buprenorphine.I have been on a stable dose of 20-90 MME oral opioids for 3 months.I am currently taking opioid medications, including Methadone.I am on long-acting opioid painkillers.I am using a pain relief patch for my pain.I am scheduled for knee or hip replacement surgery in the next 4-8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmacist-led opioid taper intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently admitting participants?
"According to the information provided on clinicaltrials.gov, this particular trial is not currently accepting applications. It was posted initially in April 1st 2023 and last updated on March 15th 2023. Although no longer recruiting participants, there are 803 other studies presently seeking candidates."
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