Opioid DependenceEarly Phase 1NCT04883983
OLP to Manage Pain in TJA: A Feasibility Study
A Early Phase 1 study testing Patient medication as standardly prescribed in people with Opioid Dependence and Opioid Abuse, run by University of Alabama at Birmingham.
Trial summary
Persistent opioid abuse presents a common yet under-recognized problem given the decreasing rates of morbidity and mortality following common elective surgical procedures, like total joint arthroplasty (TJA). Each year around 33-70% of patients seeking surgical procedures in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Opioid Abuse
- What is being tested?
- Patient medication as standardly prescribed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Oct 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants eligible to undergo the TJA surgical procedure
Who cannot join
- Participants who are not eligible to undergo the TJA surgical procedure i.e. (participants who are morbidly obese or with comorbidities that make them ineligible for the surgery)
About this study
Official title: Open Label Placebo to Manage Pain in Total Joint Arthroplasty: A Feasibility Study
Persistent opioid abuse presents a common yet under-recognized problem given the decreasing rates of morbidity and mortality following common elective surgical procedures, like total joint arthroplasty (TJA). Each year around 33-70% of patients seeking surgical procedures in the U.S. transition to persistent opioid use following elective surgery (such as TJA), primarily prescribed for post-operative pain management. Further, these patients are more likely to demand greater doses and for longer duration post-surgery due to maladaptive neurologic changes occurring in key areas of the brain. The purpose of this study is to see if it is feasible to use OLP (open label placebo) for post-operative pain management in the post TJA setting. In addition the investigators will also collect pilot data to compare key outcome measures (patient reported physical function related to osteoarthritis of the hip and knee, pain score, and health-related quality of life will be assessed) between the placebo and the Treatment-As-Usual (TAU) group over a 90-day post-operative period.
Read the detailed description
The investigators will enroll 24 adults that have undergone primary total joint arthroplasty and are requesting additional pain medication at 2 weeks. Once informed, consented and enrolled, participants will be assessed, randomized to either open-label placebo (OLP) or treatment-as-usual (TUA). Participants will be informed on why the OLP may manage the symptoms of postoperative pain and the benefits of OLP vs an Opioid. Patients randomized to OLP will be given placebo pills at their 2 week follow-up appointment (baseline) if additional pain medication is requested. Patients will be instructed to utilize placebo pill in the same manner as their previous medication. If interested, the participant will be consented in clinic and a consent signed in person. Pain control, joint function, and quality of life assessment scores will be conducted at 2, 6, and 12 week follow-up visits in clinic. After randomization, the placebo group will receive a scripted orientation that mimics a typical patient-provider interaction when prescribing a pain medication, including the rationale for effectiveness and the importance of taking the placebo pills as prescribed.
Open-label placebo adherence will be assessed using pill count. The investigators will ask all participants to maintain their current treatment regimens over the course of the study. After 12 weeks, all participants will complete final assessments. Participants in the OLP group will be monitored in clinic to allow for additional pain control if required.
Study outcomes will be measured using SF-36 quality of life score, Visual Analog Scale, Hip disability and Osteoarthritis Outcome Score, and Knee disability and Osteoarthritis Outcome Score. The investigators will also collect information about potential moderators that would include demographic data (e.g., age, years since diagnosis, treatments, gender), use of disease modifying therapies (oral versus infusion), types of medications, total number of medications, history of opioid abuse, history of opioid use, presence of a diagnosed cognitive or psychiatric disorder, mood disorder.
ANCOVA will be used to measure treatment effect with baseline measurement used as a covariate. Effect sizes and estimates of correlation between pre-post measures will be estimated.
- Conditions
- Opioid Dependence, Opioid Abuse
- Being tested
- Open Label Placebo, Patient medication as standardly prescribed
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Label PlaceboDrug
Pain medication will be prescribed per standard treatment for initial prescription. Pain medication request at followup will be filled with open label placebo. Pain assessment surveys will be used at 2, 6, and 12 week followups.
Patient medication as standardly prescribedDrug
Pain medication will be prescribed per standard treatment for initial prescription. On request for additional pain medication, pain medication will be prescribed as per the standard protocol. Pain assessment surveys will be used at 2, 6, and 12 week followups.
| Study group | Role | What they receive |
|---|---|---|
| Pain Medication as Standardly Prescribed | Active comparator | Patients will receive pain medication as standardly prescribed. Refills at the 2 week followup will be provided as per the standard treatment protocol. Receives: Drug: Patient medication as standardly prescribed |
| Open Label Placebo | Experimental | Initial post-op pain medication will be prescribed. On 2 week followup, refill request will be filled with an open label placebo. Receives: Drug: Open Label Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Measured: 2 weeks (Baseline)
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Measured: 6 weeks
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Measured: 12 weeks
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Week 2 (Baseline)
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Week 6
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Week 12
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Measured: Baseline 2 weeks
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Measured: 6 weeks
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Measured: 12 weeks
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Measured: Baseline 2 weeks
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Measured: 6 weeks
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study startDec 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Study was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tapan Shirish Mehta, University of Alabama at Birmingham
- Investigators
- Sameer Naranje, Principal investigator, University of Alabama at BirminghamTapan Mehta, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883983
- Sponsor's protocol ID
- IRB-300006920
- Other IDs
- UAB
- Status last verified
- May 2025
- First submitted
- 8 Apr 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Placebo to Manage Pain in Total Joint Arthroplasty: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04883983
- Acronym / sponsor ID
- IRB-300006920
- Conditions
- Opioid Dependence, Opioid Abuse
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistent opioid abuse presents a common yet under-recognized problem given the decreasing rates of morbidity and mortality following common elective surgical procedures, like total joint arthroplasty (TJA). Each year around 33-70% of patients seeking surgical procedures in the U.S. transition to persistent opioid use following elective surgery (such as TJA), primarily prescribed for post-operative pain management. Further, these patients are more likely to demand greater doses and for longer duration post-surgery due to maladaptive neurologic changes occurring in key areas of the brain. The purpose of this study is to see if it is feasible to use OLP (open label placebo) for post-operative pain management in the post TJA setting. In addition the investigators will also collect pilot data to compare key outcome measures (patient reported physical function related to osteoarthritis of the hip and knee, pain score, and health-related quality of life will be assessed) between the placebo and the Treatment-As-Usual (TAU) group over a 90-day post-operative period.
Detailed description
The investigators will enroll 24 adults that have undergone primary total joint arthroplasty and are requesting additional pain medication at 2 weeks. Once informed, consented and enrolled, participants will be assessed, randomized to either open-label placebo (OLP) or treatment-as-usual (TUA). Participants will be informed on why the OLP may manage the symptoms of postoperative pain and the benefits of OLP vs an Opioid. Patients randomized to OLP will be given placebo pills at their 2 week follow-up appointment (baseline) if additional pain medication is requested. Patients will be instructed to utilize placebo pill in the same manner as their previous medication. If interested, the participant will be consented in clinic and a consent signed in person. Pain control, joint function, and quality of life assessment scores will be conducted at 2, 6, and 12 week follow-up visits in clinic. After randomization, the placebo group will receive a scripted orientation that mimics a typical patient-provider interaction when prescribing a pain medication, including the rationale for effectiveness and the importance of taking the placebo pills as prescribed.
Open-label placebo adherence will be assessed using pill count. The investigators will ask all participants to maintain their current treatment regimens over the course of the study. After 12 weeks, all participants will complete final assessments. Participants in the OLP group will be monitored in clinic to allow for additional pain control if required.
Study outcomes will be measured using SF-36 quality of life score, Visual Analog Scale, Hip disability and Osteoarthritis Outcome Score, and Knee disability and Osteoarthritis Outcome Score. The investigators will also collect information about potential moderators that would include demographic data (e.g., age, years since diagnosis, treatments, gender), use of disease modifying therapies (oral versus infusion), types of medications, total number of medications, history of opioid abuse, history of opioid use, presence of a diagnosed cognitive or psychiatric disorder, mood disorder.
ANCOVA will be used to measure treatment effect with baseline measurement used as a covariate. Effect sizes and estimates of correlation between pre-post measures will be estimated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Medication as Standardly Prescribed | Active comparator | Drug: Patient medication as standardly prescribedPatients will receive pain medication as standardly prescribed. Refills at the 2 week followup will be provided as per the standard treatment protocol. |
| Open Label Placebo | Experimental | Drug: Open Label PlaceboInitial post-op pain medication will be prescribed. On 2 week followup, refill request will be filled with an open label placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants eligible to undergo the TJA surgical procedure
Key exclusion criteria (1 listed)
- Participants who are not eligible to undergo the TJA surgical procedure i.e. (participants who are morbidly obese or with comorbidities that make them ineligible for the surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Label PlaceboPain medication will be prescribed per standard treatment for initial prescription. Pain medication request at followup will be filled with open label placebo. Pain assessment surveys will be used at 2, 6, and 12 week followups. | Drug | Open Label Placebo |
| Patient medication as standardly prescribedPain medication will be prescribed per standard treatment for initial prescription. On request for additional pain medication, pain medication will be prescribed as per the standard protocol. Pain assessment surveys will be used at 2, 6, and 12 week followups. | Drug | Pain Medication as Standardly Prescribed |
Primary outcome
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Time frame: 2 weeks (Baseline)
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Time frame: 6 weeks
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Time frame: 12 weeks
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Time frame: Week 2 (Baseline)
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Time frame: Week 6
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Time frame: Week 12
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Time frame: Baseline 2 weeks
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Time frame: 6 weeks
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Time frame: 12 weeks
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Time frame: Baseline 2 weeks
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Time frame: 6 weeks
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Time frame: 12 weeks
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer Naranje principal investigator
University of Alabama at Birmingham
Tapan Mehta principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Patient medication as standardly prescribed in people with Opioid Dependence and Opioid Abuse, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale (time frame: 2 weeks (Baseline)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.