Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development

The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are:

• Is the intervention feasible and acceptable to patients?
• Does the intervention result in a decrease in opioid dose during the 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Arthritis Knee; Arthritis Hip
• Intervention / Treatment: Behavioral: opioid taper

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin R Riggs, MD; Phone Number: 205-934-0778; Email: kriggs@uabmc.edu
• Study Contact Backup: Name: Shakristal Williams; Phone Number: 205-934-2304; Email: shakristalwilliams@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • UAB Hospital-Highlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• decided to pursue primary, unilateral total knee or hip arthroplasty with planned surgery date in 4-8 weeks
• currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
• have a reliable telephone number for contact
• speaks English

Exclusion Criteria:

• Taking opioid medications that include:

  • Buprenorphine
  • Methadone
  • Long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine)
  • Transdermal formations of opioid pain medications (e.g., fentanyl patches)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pharmacist-led opioid taper 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.

Behavioral: opioid taper; The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Mixed-methods assessment of the intervention by participants. Participants will provide qualitative feedback at multiple points during and after the intervention, and will quantitatively rate satisfaction at the end of the study. These results will be analyzed jointly to determine acceptability.	From enrollment until approximately 2 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Recruitment Rate	In order to assess feasibility of the taper intervention, we will track the proportion of participants who are offered enrollment that ultimately enroll (will be measured separately for those offered enrollment in person and those who are mailed information about the study)	From enrollment until approximately 2 weeks after surgery
Study Retention Rate	In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit.	From enrollment until approximately 2 weeks after surgery
Taper Efficacy	change in opioid dose from enrollment through surgery	From enrollment until the time of surgery
Perioperative Pain	pain scores throughout the perioperative period	From enrollment until approximately 2 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Kevin R Riggs, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Opioids
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: IRB-300009887; 1K23AR080224-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No