Opioid UsePhase 4NCT03534102
Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption
A Phase 4 study testing Improved Opioid-Tapering Instructions and Clinical Patient Educator in people with Opioid Use and Opioid Dependence, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid Dependence, Knee Pain Chronic
- What is being tested?
- Improved Opioid-Tapering Instructions and Clinical Patient Educator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 1 Sep 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Date of surgery between 3 weeks and 8 weeks away
- Undergoing total hip or total knee replacement [including simultaneous bilateral]
- Eligible based on our standard Faulkner Hospital pre-op assessment
Who cannot join
- If female, pregnant
- Undergoing partial joint replacement
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
About this study
This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing narcotic consumption when used in conjunction with improved educational materials. Furthermore, the investigators would like to investigate the effect of the patient-maintained diaries, the improved educational materials, and the pain management counselor on pain levels, nausea, sleep quality, and patient satisfaction.
All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and choose to participate will be assigned to a treatment group based on which arm of the study is being tested at the time; (the treatment arms are sequential). Members of Group 1 (control group) will receive the current standardized institutional discharge care for orthopedic surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive more detailed educational materials regarding postoperative pain management - including instructions to how to taper their narcotic usage - as well as a tracking diary. Members of Group 3 (experimental group 2) will receive not only the educational materials of Group 2, but also weekly phone calls from a clinical patient educator to remind them of proper use of the diary and narcotic tapering.
Read the detailed description
This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing narcotic consumption when used in conjunction with improved educational materials. Furthermore, the investigators would like to investigate the effect of the patient-maintained diaries, the improved educational materials, and the pain management counselor on pain levels, nausea, sleep quality, and patient satisfaction. The enrollment of the study will depend on the amount of patients that fall into each treatment arm - each of which will last for a fixed period of time. The expected enrollment is approximately 1000-1200 patients.
All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked whether they would like to participate. Those who agree will be assigned to a treatment group based on which arm of the study is being tested at the time (the treatment arms are sequential). Members of Group 1 (control group) will receive the current standardized institutional discharge care for orthopedic surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive more detailed educational materials regarding postoperative pain management - including instructions to how to taper their narcotic usage - as well as a tracking diary. Members of Group 3 (experimental group 2) will receive not only the educational materials of Group 2, but also regular phone calls from a clinical patient educator to remind them of proper use of the diary and narcotic tapering.
Each enrolled patient will be given verbal and written (printed and/or electronic format) instructions about narcotic medication by the nursing staff upon hospital discharge. The instructions will explain when to use such medications, how to taper off them, and how to document them. Following discharge, patients will record their opioid consumption on their own and document their pain, nausea, sleep and satisfaction. At the first post-operative appointment, patients' levels of opioid use will be recorded and actual tablets consumed compared with prescription received. If they receive a new prescription they will receive a matching diary for the total length of planned opioid treatment, including directions on how to wean themselves off the opioids. Outcome measures will be collected at both post-operative visits, the first a week after surgery and the second 2-3 months following. Additional data including length of stay, postoperative complications including infection and readmission, Emergency Department visits, and routinely collected postoperative functional outcome measures (PROMs) will be recorded.
The Principal Investigator (PI) will review all pain, satisfaction, narcotic usage and proprioception data on a weekly basis with the research assistant (RA) as it is collected. These checks will help to ensure validity and patient safety. Privacy and confidentially will be assured by using codes as deidentifiers in place of identifying information on any data sheets used in analysis. Data which identifies the patient will be made available only to investigators and stored only in a private folder on department computers protected with a firewall. No data will be shared outside of Partners. Adverse events will be promptly reported to the Partners Human Research Committee (PHRC) as per PHRC rules.
- Conditions
- Opioid Use, Opioid Dependence, Knee Pain Chronic, Knee Osteoarthritis
- Being tested
- Improved Opioid-Tapering Instructions, Clinical Patient Educator
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Opioid Dependence, Opioid Tapering
- Medical subject headings
- Opioid-Related Disorders, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved Opioid-Tapering InstructionsDrug
Applied to first and second experimental groups in the form of discharge instructions and directions from nursing staff.
Clinical Patient EducatorBehavioural
Applied to second experimental group in the form of regular calls about weaning off narcotic medications.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard instructions from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary. |
| Improved Instructions | Experimental | Improved opioid-tapering instructions given upon discharge from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary. Receives: Drug: Improved Opioid-Tapering Instructions |
| Improved Instructions and Educator | Experimental | Improved opioid-tapering instructions given upon discharge from hospital. Subject receives regular phone calls from educator for counseling in opioid tapering. Subjects record opioid tapering in diary. Receives: Drug: Improved Opioid-Tapering Instructions; Behavioral: Clinical Patient Educator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption: Amount
Total amount of patients' opioid consumption, measured in mg of morphine equivalents.
Measured: 2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
Opioid Usage After One Week
The proportion of patients who have finished taking opioids by the first postoperative appointment, approximately one week after surgery.
Measured: 7 days following surgery.
Total Opioid Consumption: Days
The total number of days in which each patient took opioid medications after surgery.
Measured: 2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
Secondary outcomes (7)
Opioid Usage After Two Weeks
The proportion of patients who have finished taking opioids two weeks after surgery.
Measured: 14 days following surgery.
Visual Analogue Scale (VAS) Score 1: "How much pain do you feel in your operative site when resting?"
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
Measured: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 2: "How much pain do you feel in your operative site when moving?"
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
Measured: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 3: "How well are you sleeping?"
Sleep quality. Scale 0-10 with 0 worst and 10 best.
Measured: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 4: "How bad is your nausea?"
Nausea. Scale 0-10, with 0 best and 10 worst.
Measured: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 5: "How satisfied are you with your pain management?"
Satisfaction. Scale 0-10 with 0 worst and 10 best.
Measured: 2-3 months following surgery (measured at second postoperative appointment).
Questionnaire Answers
Questionnaire given to patients 3 months after surgery. Patients are asked about how opioid medications are typically stored and consumed at home.
Measured: 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start6 Jun 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Why it stopped: Due to limitations caused by COVID, enrollment targets could not be met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Testing 3 sequential standards of care; each of 3 arms lasts 4 months, and all patients recruited within an arm are assigned to the same treatment.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Fitz, M.D., Brigham and Women's Hospital
- Investigators
- Wolfgang Fitz, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534102
- Sponsor's protocol ID
- OpioidTaperingTKR/THR
- Status last verified
- Feb 2023
- First submitted
- 24 Apr 2018
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon DB, de Leon-Casasola OA, Wu CL, Sluka KA, Brennan TJ, Chou R. Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings From a Review of the Evidence for an American Pain Society Clinical Practice Guideline. J Pain. 2016 Feb;17(2):158-66. doi: 10.1016/j.jpain.2015.10.023. Epub 2015 Dec 21.
PubMed 26719073Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Reynolds MA. Postoperative pain management discharge teaching in a rural population. Pain Manag Nurs. 2009 Jun;10(2):76-84. doi: 10.1016/j.pmn.2008.07.003. Epub 2009 Jan 4.
PubMed 19481046Wakim JH. Alleviating symptoms of withdrawal from an opioid. Pain Ther. 2012 Dec;1(1):4. doi: 10.1007/s40122-012-0004-5. Epub 2012 Sep 20.
PubMed 25134933Ninkovic J, Roy S. Morphine decreases bacterial phagocytosis by inhibiting actin polymerization through cAMP-, Rac-1-, and p38 MAPK-dependent mechanisms. Am J Pathol. 2012 Mar;180(3):1068-1079. doi: 10.1016/j.ajpath.2011.11.034. Epub 2012 Jan 14.
PubMed 22248582Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
PubMed 26871536
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption
- ClinicalTrials.gov ID
- NCT03534102
- Acronym / sponsor ID
- OpioidTaperingTKR/THR
- Conditions
- Opioid Use, Opioid Dependence, Knee Pain Chronic, Knee Osteoarthritis
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Opioid Dependence, Opioid Tapering
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to limitations caused by COVID, enrollment targets could not be met.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 6 Jun 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 23 May 2018 (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.
This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing narcotic consumption when used in conjunction with improved educational materials. Furthermore, the investigators would like to investigate the effect of the patient-maintained diaries, the improved educational materials, and the pain management counselor on pain levels, nausea, sleep quality, and patient satisfaction.
All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and choose to participate will be assigned to a treatment group based on which arm of the study is being tested at the time; (the treatment arms are sequential). Members of Group 1 (control group) will receive the current standardized institutional discharge care for orthopedic surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive more detailed educational materials regarding postoperative pain management - including instructions to how to taper their narcotic usage - as well as a tracking diary. Members of Group 3 (experimental group 2) will receive not only the educational materials of Group 2, but also weekly phone calls from a clinical patient educator to remind them of proper use of the diary and narcotic tapering.
Detailed description
This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing narcotic consumption when used in conjunction with improved educational materials. Furthermore, the investigators would like to investigate the effect of the patient-maintained diaries, the improved educational materials, and the pain management counselor on pain levels, nausea, sleep quality, and patient satisfaction. The enrollment of the study will depend on the amount of patients that fall into each treatment arm - each of which will last for a fixed period of time. The expected enrollment is approximately 1000-1200 patients.
All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked whether they would like to participate. Those who agree will be assigned to a treatment group based on which arm of the study is being tested at the time (the treatment arms are sequential). Members of Group 1 (control group) will receive the current standardized institutional discharge care for orthopedic surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive more detailed educational materials regarding postoperative pain management - including instructions to how to taper their narcotic usage - as well as a tracking diary. Members of Group 3 (experimental group 2) will receive not only the educational materials of Group 2, but also regular phone calls from a clinical patient educator to remind them of proper use of the diary and narcotic tapering.
Each enrolled patient will be given verbal and written (printed and/or electronic format) instructions about narcotic medication by the nursing staff upon hospital discharge. The instructions will explain when to use such medications, how to taper off them, and how to document them. Following discharge, patients will record their opioid consumption on their own and document their pain, nausea, sleep and satisfaction. At the first post-operative appointment, patients' levels of opioid use will be recorded and actual tablets consumed compared with prescription received. If they receive a new prescription they will receive a matching diary for the total length of planned opioid treatment, including directions on how to wean themselves off the opioids. Outcome measures will be collected at both post-operative visits, the first a week after surgery and the second 2-3 months following. Additional data including length of stay, postoperative complications including infection and readmission, Emergency Department visits, and routinely collected postoperative functional outcome measures (PROMs) will be recorded.
The Principal Investigator (PI) will review all pain, satisfaction, narcotic usage and proprioception data on a weekly basis with the research assistant (RA) as it is collected. These checks will help to ensure validity and patient safety. Privacy and confidentially will be assured by using codes as deidentifiers in place of identifying information on any data sheets used in analysis. Data which identifies the patient will be made available only to investigators and stored only in a private folder on department computers protected with a firewall. No data will be shared outside of Partners. Adverse events will be promptly reported to the Partners Human Research Committee (PHRC) as per PHRC rules.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Testing 3 sequential standards of care; each of 3 arms lasts 4 months, and all patients recruited within an arm are assigned to the same treatment.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard instructions from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary. |
| Improved Instructions | Experimental | Drug: Improved Opioid-Tapering InstructionsImproved opioid-tapering instructions given upon discharge from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary. |
| Improved Instructions and Educator | Experimental | Drug: Improved Opioid-Tapering Instructions, Behavioral: Clinical Patient EducatorImproved opioid-tapering instructions given upon discharge from hospital. Subject receives regular phone calls from educator for counseling in opioid tapering. Subjects record opioid tapering in diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Date of surgery between 3 weeks and 8 weeks away
- Undergoing total hip or total knee replacement [including simultaneous bilateral]
- Eligible based on our standard Faulkner Hospital pre-op assessment
Key exclusion criteria (2 listed)
- If female, pregnant
- Undergoing partial joint replacement
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 |
|---|---|---|
| Improved Opioid-Tapering InstructionsApplied to first and second experimental groups in the form of discharge instructions and directions from nursing staff. | Drug | Improved Instructions, Improved Instructions and Educator |
| Clinical Patient EducatorApplied to second experimental group in the form of regular calls about weaning off narcotic medications. | Behavioural | Improved Instructions and Educator |
Primary outcome
Total Opioid Consumption: Amount
Time frame: 2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
Total amount of patients' opioid consumption, measured in mg of morphine equivalents.
Opioid Usage After One Week
Time frame: 7 days following surgery.
The proportion of patients who have finished taking opioids by the first postoperative appointment, approximately one week after surgery.
Total Opioid Consumption: Days
Time frame: 2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).
The total number of days in which each patient took opioid medications after surgery.
7 secondary outcomes
Opioid Usage After Two Weeks
Time frame: 14 days following surgery.
Visual Analogue Scale (VAS) Score 1: "How much pain do you feel in your operative site when resting?"
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 2: "How much pain do you feel in your operative site when moving?"
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 3: "How well are you sleeping?"
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 4: "How bad is your nausea?"
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 5: "How satisfied are you with your pain management?"
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
Questionnaire Answers
Time frame: 3 months after surgery.
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 27 Feb 2023.
- Background: PubMed 26719073Gordon DB, de Leon-Casasola OA, Wu CL, Sluka KA, Brennan TJ, Chou R. Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings From a Review of the Evidence for an American Pain Society Clinical Practice Guideline. J Pain. 2016 Feb;17(2):158-66. doi: 10.1016/j.jpain.2015.10.023. Epub 2015 Dec 21.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Background: PubMed 19481046Reynolds MA. Postoperative pain management discharge teaching in a rural population. Pain Manag Nurs. 2009 Jun;10(2):76-84. doi: 10.1016/j.pmn.2008.07.003. Epub 2009 Jan 4.
- Background: PubMed 25134933Wakim JH. Alleviating symptoms of withdrawal from an opioid. Pain Ther. 2012 Dec;1(1):4. doi: 10.1007/s40122-012-0004-5. Epub 2012 Sep 20.
- Background: PubMed 22248582Ninkovic J, Roy S. Morphine decreases bacterial phagocytosis by inhibiting actin polymerization through cAMP-, Rac-1-, and p38 MAPK-dependent mechanisms. Am J Pathol. 2012 Mar;180(3):1068-1079. doi: 10.1016/j.ajpath.2011.11.034. Epub 2012 Jan 14.
- Background: PubMed 26871536Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
- Carr DB, Morlion B. Pain After Surgery: What Health-Care Professionals Should Know.Link provided by the sponsor.
- 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.
Wolfgang Fitz, MD principal investigator
Brigham and Women's Hospital
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 Improved Opioid-Tapering Instructions and Clinical Patient Educator in people with Opioid Use and Opioid Dependence, run by Brigham and Women's Hospital 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 4 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: withdrawn, as of the sponsor's last update on 27 Feb 2023. 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?
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?
Total Opioid Consumption: Amount (time frame: 2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534102, which also lists 6 linked publications.
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 27 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.