Arthritis KneeNCT05788016
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
A study testing opioid taper in people with Arthritis Knee and Arthritis Hip, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Knee, Arthritis Hip, Chronic Pain
- What is being tested?
- opioid taper
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development
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
- Being tested
- opioid taper
- Keywords
- Opioids
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid taperBehavioural
The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: opioid taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until approximately 2 weeks after surgery
Secondary outcomes (4)
Study Recruitment Rate
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)
Measured: From enrollment until approximately 2 weeks after surgery
Study Retention Rate
In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit.
Measured: From enrollment until approximately 2 weeks after surgery
Taper Efficacy
change in opioid dose from enrollment through surgery
Measured: From enrollment until the time of surgery
Perioperative Pain
pain scores throughout the perioperative period
Measured: From enrollment until approximately 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start10 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kevin Riggs, University of Alabama at Birmingham
- Investigators
- Kevin R Riggs, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788016
- Sponsor's protocol ID
- IRB-300009887
- Other IDs
- 1K23AR080224-01A1
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No