Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

NCT05788016 | Recruiting DMC

• 2 other identifiers: IRB-3000098871K23AR080224-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Opioids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Study Recruitment Rate

  From enrollment until approximately 2 weeks after surgery

• Study Retention Rate

  From enrollment until approximately 2 weeks after surgery

• Taper Efficacy

  From enrollment until the time of surgery

• Perioperative Pain

  From enrollment until approximately 2 weeks after surgery

Study Arms (1)

Pharmacist-led opioid taper intervention

EXPERIMENTAL

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

Interventions

opioid taper BEHAVIORAL

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

Pharmacist-led opioid taper intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UAB Hospital-Highlands

Birmingham, Alabama, 35205, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin R Riggs, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin R Riggs, MD

CONTACT

205-934-0778; kriggs@uabmc.edu

Shakristal Williams

CONTACT

205-934-2304; shakristalwilliams@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 28, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)