Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05788016

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

Led by University of Alabama at Birmingham · Updated on 2026-05-29

45

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to develop and evaluate a pharmacist-led opioid taper intervention for adults with chronic opioid use who are preparing for total knee or hip replacement surgery. It seeks to determine if the intervention is feasible and acceptable to patients and whether it can reduce opioid dose before surgery. The study is led by the University of Alabama at Birmingham and focuses on patients with arthritis-related chronic pain undergoing joint replacement. Participants will work with a clinical pharmacist who will provide education about pain and opioid use and suggest a tapering plan to reduce opioid intake by about 50% over a 4 to 6 week period before surgery. The pharmacist will follow up weekly by phone to support progress and adjust the taper schedule as needed during this preoperative phase. During the study, participants' acceptability of the intervention and recruitment and retention rates will be monitored from enrollment until roughly two weeks after surgery. Researchers will also assess taper effectiveness and perioperative pain levels. The total participation involves the preoperative period and a short postoperative follow-up to evaluate outcomes related to opioid use and pain management.

CONDITIONS

Brief Title

Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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, with a stable dose for at least 3 months
  • Have a reliable telephone number for contact
  • Speaks English
Not Eligible

You will not qualify if you...

  • Taking opioid medications that include buprenorphine
  • Taking methadone
  • Taking long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine)
  • Taking transdermal formulations of opioid pain medications (e.g., fentanyl patches)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Outpatient Treatment

Duration - 4 to 6 weeks

Participants attempt to taper their opioid dose by about 50% during the 4 to 6 week preoperative period. They meet with a clinical pharmacist who provides education on pain and opioids and proposes a taper schedule. The pharmacist follows up weekly by phone to assess progress and adjust the taper as needed.

Weekly phone follow-up visits until surgery

Post-operative Follow-up

Duration - Approximately 2 weeks after surgery

Participants are monitored for acceptability, retention, recruitment, taper efficacy, and perioperative pain from enrollment until approximately 2 weeks after surgery.

Follow-up visits as scheduled after surgery

Trial Site Locations

Total: 1 location

1

UAB Hospital-Highlands

Birmingham, Alabama, United States, 35205

Actively Recruiting

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Research Team

K

Kevin R Riggs, MD

S

Shakristal Williams

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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