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Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05788016
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Alabama at Birmingham
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kevin R Riggs, MD
Principal Investigator Affiliation University of Alabama at Birmingham
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthritis Knee, Arthritis Hip, Chronic Pain
Arms & Interventions

Arms

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.

Interventions

Behavioral: - opioid taper

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UAB Hospital-Highlands, Birmingham, Alabama

Status

Recruiting

Address

UAB Hospital-Highlands

Birmingham, Alabama, 35205

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