Opioid AbusePhase 4NCT05363436
Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed
A Phase 4 study testing Oxycodone in people with Opioid Abuse and Opioid Misuse, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Investigators studied a baseline population of patients receiving pancreatectomies at their institution and determined how many opioid pills each patient was prescribed and how many they took. Based on this data they created a toolkit to provide to prescribers to give patients a modified number of pills. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Abuse, Opioid Misuse, Pain
- What is being tested?
- Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to Dec 2028
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Being scheduled for an outpatient elective pancreatectomy
Who cannot join
- Urgent/emergent status
- Concomitant procedure being performed at time of pancreatectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Successful Implementation of an Opioid Reduction Toolkit in Pancreatectomy Patients Significantly Decreases Number of Opioids Prescribed and Consumed
Investigators studied a baseline population of patients receiving pancreatectomies at their institution and determined how many opioid pills each patient was prescribed and how many they took. Based on this data they created a toolkit to provide to prescribers to give patients a modified number of pills. The amount prescribed and consumed was measured after intervention.
Read the detailed description
A single academic surgical department reviewed opioid treatment patterns for patients undergoing common procedures, including open pancreatectomy, and an opioid reduction toolkit using the data collected was created. Providers were educated on the use of the toolkit and it was implemented as a standard of practice. Data were collected on pancreatectomy patients via telephone interview (performed at 2 weeks post-op) and by reviewing the state prescription drug monitoring program. Outcome variables included morphine milliequivalents (MME) of pills prescribed, MME of pills consumed, number of patients aware of proper unused pill disposal, number of patients requesting refills, and pain scores. Categorical and continuous outcomes were compared within and between groups.
- Conditions
- Opioid Abuse, Opioid Misuse, Pain
- Being tested
- Oxycodone
- Medical subject headings
- Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Providers had to prescribe 15 oxycodone pills to each patient discharge
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Normal Standard Practices of Prescribing |
| Intervention | Experimental | Providers prescribed a base of 15 narcotic pills Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of opioid pills reported being taken by the patient
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Measured: 14 days
Number of opioid pills being prescribed
Discharge paperwork and prescription information will be searched to determine the number of opioid pills were provided to the patient at discharge
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Jan 2018
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Recruitment Reorganzing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control group, measurement, intervention group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363436
- Sponsor's protocol ID
- 19D.688Panc
- Status last verified
- Apr 2024
- First submitted
- 2 May 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Implementation of an Opioid Reduction Toolkit in Pancreatectomy Patients Significantly Decreases Number of Opioids Prescribed and Consumed
- ClinicalTrials.gov ID
- NCT05363436
- Acronym / sponsor ID
- 19D.688Panc
- Conditions
- Opioid Abuse, Opioid Misuse, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment Reorganzing
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 May 2022 (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.
Investigators studied a baseline population of patients receiving pancreatectomies at their institution and determined how many opioid pills each patient was prescribed and how many they took. Based on this data they created a toolkit to provide to prescribers to give patients a modified number of pills. The amount prescribed and consumed was measured after intervention.
Detailed description
A single academic surgical department reviewed opioid treatment patterns for patients undergoing common procedures, including open pancreatectomy, and an opioid reduction toolkit using the data collected was created. Providers were educated on the use of the toolkit and it was implemented as a standard of practice. Data were collected on pancreatectomy patients via telephone interview (performed at 2 weeks post-op) and by reviewing the state prescription drug monitoring program. Outcome variables included morphine milliequivalents (MME) of pills prescribed, MME of pills consumed, number of patients aware of proper unused pill disposal, number of patients requesting refills, and pain scores. Categorical and continuous outcomes were compared within and between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group, measurement, intervention group
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Normal Standard Practices of Prescribing |
| Intervention | Experimental | Drug: OxycodoneProviders prescribed a base of 15 narcotic pills |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Being scheduled for an outpatient elective pancreatectomy
Key exclusion criteria (2 listed)
- Urgent/emergent status
- Concomitant procedure being performed at time of pancreatectomy
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 |
|---|---|---|
| OxycodoneProviders had to prescribe 15 oxycodone pills to each patient discharge | Drug | Intervention |
Primary outcome
Number of opioid pills reported being taken by the patient
Time frame: 14 days
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Number of opioid pills being prescribed
Time frame: 14 days
Discharge paperwork and prescription information will be searched to determine the number of opioid pills were provided to the patient at discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone in people with Opioid Abuse and Opioid Misuse, run by Thomas Jefferson University at 1 site in United States.
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 2 inclusion and 2 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: paused, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of opioid pills reported being taken by the patient (time frame: 14 days). The study lists 2 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 22 Apr 2024.