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NCT Number: NCT05788016

Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

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.

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Key information

Conditions

Arthritis Knee Arthritis Hip Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Hospital-Highlands

Birmingham, Alabama, 35205, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

opioid taper

Behavioral

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

Primary outcomes

  1. Acceptability

    Time frame: From enrollment until approximately 2 weeks after surgery

    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.

Secondary outcomes

  1. Study Recruitment Rate

    Time frame: From enrollment until approximately 2 weeks after surgery

    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)

  2. Study Retention Rate

    Time frame: From enrollment until approximately 2 weeks after surgery

    In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit.

  3. Taper Efficacy

    Time frame: From enrollment until the time of surgery

    change in opioid dose from enrollment through surgery

  4. Perioperative Pain

    Time frame: From enrollment until approximately 2 weeks after surgery

    pain scores throughout the perioperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin R Riggs, MD

CONTACT

[email protected]

205-934-0778

Shakristal Williams

CONTACT

[email protected]

205-934-2304

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 28, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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