Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

NCT ID: NCT05788016

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2026-09-01

Brief Summary

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.

Conditions

Arthritis Knee; Arthritis Hip; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

opioid taper

Intervention Type: BEHAVIORAL

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

Interventions

opioid taper

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Kevin Riggs

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin R Riggs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Hospital-Highlands

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kevin R Riggs, MD

Role: CONTACT

kriggs@uabmc.edu

205-934-0778

Shakristal Williams

Role: CONTACT

shakristalwilliams@uabmc.edu

205-934-2304

Other Identifiers

1K23AR080224-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300009887

Identifier Type: -

Identifier Source: org_study_id