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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
Currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
Be older than 18 years old
Must not have
Taking opioid medications that include Buprenorphine
Taking opioid medications that include Methadone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until approximately 2 weeks after surgery
Awards & highlights
No Placebo-Only Group
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.
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.
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 been on a stable dose of 20-90 MME oral opioids for 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking opioid medication that includes Buprenorphine.
Select...
I am currently taking opioid medications, including Methadone.
Select...
I am on long-acting opioid painkillers.
Select...
I am using a pain relief patch for my pain.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Secondary study objectives
Perioperative Pain
Study Recruitment Rate
Study Retention Rate
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
1,656 Previous Clinical Trials
2,444,330 Total Patients Enrolled
7 Trials studying Chronic Pain
5,935 Patients Enrolled for Chronic Pain
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,973 Total Patients Enrolled
10 Trials studying Chronic Pain
854 Patients Enrolled for Chronic Pain
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.