Pain, ChronicNCT03248765
Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use
An observational study of Pain, Chronic and Opioid Use, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if the research results obtained in animal models of pain - that show that being in pain for some time increases opioid use beyond what is expected to treat the current pain - also apply to patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic, Opioid Use
- What is being tested?
- post-surgical opioid use measured at 1 day and 1 week.
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 11 Sep 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Patients with and without chronic musculoskeletal pain or osteoarthritis pain that are having planned non-cancer related surgery
Who may be able to join
- Age 18-65
- With and without history of chronic muscle-skeletal pain *
- Scheduled to undergo elective abdominal surgery requiring overnight hospital admission
- Opioid naïve**
- Willing to comply with study procedures as outlined in the protocol
- Willing and able to provide informed consent
- Having an email address and access to a computer or electronic tablet
Who cannot join
- Current use of opioids (includes ANY use in past 3 months)
- Cancer diagnosis
- Patient presenting the following documented conditions:
- Untreated psychosis Current suicidal ideation Current substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this study is to determine if the research results obtained in animal models of pain - that show that being in pain for some time increases opioid use beyond what is expected to treat the current pain - also apply to patients with chronic pain.
Read the detailed description
The prevalence of chronic pain is very high in the US at approximately 30%. More than 10% of adults report having daily pain. Opioid pain medications [such as morphine] are prescribed for some pain conditions and, since they are very addictive, they can be used inappropriately and abused, to the point of causing overdose and death. This is currently a significant problem in the US and worldwide. Research on changes in the brain that cause addiction in pain patients is complicated, also because it is difficult to separate the effect of the drugs that cause addiction from the direct effect of pain on the brain. Studies in animals have found that pain per se can change the brain in ways that increase the risk of becoming addicted to pain medications. Therefore, we think that patients who have chronic pain and are prescribed opioid pain medications to treat surgery-related pain after surgery, although they never took opioids for a long time in their life, may be at increased risk of using too much opioid medications, and using opioids for a longer time than expected to treat their surgical pain.
The purpose of this study is to determine if the research results obtained in animal models of pain (that show that being in pain for some time increases opioid use beyond what is expected to treat the current pain) also apply to patients with chronic pain.
For our study we are looking to recruit patients scheduled for abdominal surgery at Barnes Jewish Hospital. If eligible and enrolled, subjects will undergo sensory testing (a test of the sensitivity of the skin to hot and cold temperature and pressure) and complete questionnaires about their experience with pain, anxiety, depression and risk of substance abuse. They will also have a one-time blood draw for genetic testing, to look for a particular gene that is potentially associated with how we respond to pain medications and, potentially, with increased risk for addiction. After the surgery, patients will be assessed by the research team on day 1, week 1, week 4, week 8, and after 6 months with similar questionnaires to those that were completed pre-surgery. Patient satisfaction with their pre-surgical and post-surgical pain control will also be assessed by questionnaire.
- Conditions
- Pain, Chronic, Opioid Use
- Being tested
- post-surgical opioid use measured at 1 day and 1 week.
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-surgical opioid use measured at 1 day and 1 week.Other
Evaluation of intra-hospital perioperative opioid administration (including intraoperative opioids and Patient Controlled Analgesia (PCA) use). This endpoint is calculated as the total amount of morphine equivalents administered intraoperatively and in the first 24 hours after the end surgery (measured on postoperative day 1).
- Opioid utilization after discharge from hospital (prescription refills and pills count at subsequent hospital visits). This endpoint is calculated as the total amount of morphine equivalents consumed in the first week after the surgery (measured at 1 week after surgery by electronic questionnaire and verified by direct pill count performed on occasion of the patient's postsurgical visit ).
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain group | post-surgical opioid use measured at 1 day and 1 week. Receives: Other: post-surgical opioid use measured at 1 day and 1 week. | |
| No chronic pain | post-surgical opioid use measured at 1 day and 1 week. Receives: Other: post-surgical opioid use measured at 1 day and 1 week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical opioid use
oral morphine equivalents (mg/day)
Measured: 24 hours post-operatively
Post-surgical opioid use
oral morphine equivalents (mg/day)
Measured: 1 week post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start30 Aug 2017
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Why it stopped: Insufficient patient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Cavallone, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248765
- Sponsor's protocol ID
- 201707017
- Status last verified
- Oct 2020
- First submitted
- 10 Aug 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use
- ClinicalTrials.gov ID
- NCT03248765
- Acronym / sponsor ID
- 201707017
- Conditions
- Pain, Chronic, Opioid Use
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient patient enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 14 Aug 2017 (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.
The purpose of this study is to determine if the research results obtained in animal models of pain - that show that being in pain for some time increases opioid use beyond what is expected to treat the current pain - also apply to patients with chronic pain.
Detailed description
The prevalence of chronic pain is very high in the US at approximately 30%. More than 10% of adults report having daily pain. Opioid pain medications [such as morphine] are prescribed for some pain conditions and, since they are very addictive, they can be used inappropriately and abused, to the point of causing overdose and death. This is currently a significant problem in the US and worldwide. Research on changes in the brain that cause addiction in pain patients is complicated, also because it is difficult to separate the effect of the drugs that cause addiction from the direct effect of pain on the brain. Studies in animals have found that pain per se can change the brain in ways that increase the risk of becoming addicted to pain medications. Therefore, we think that patients who have chronic pain and are prescribed opioid pain medications to treat surgery-related pain after surgery, although they never took opioids for a long time in their life, may be at increased risk of using too much opioid medications, and using opioids for a longer time than expected to treat their surgical pain.
The purpose of this study is to determine if the research results obtained in animal models of pain (that show that being in pain for some time increases opioid use beyond what is expected to treat the current pain) also apply to patients with chronic pain.
For our study we are looking to recruit patients scheduled for abdominal surgery at Barnes Jewish Hospital. If eligible and enrolled, subjects will undergo sensory testing (a test of the sensitivity of the skin to hot and cold temperature and pressure) and complete questionnaires about their experience with pain, anxiety, depression and risk of substance abuse. They will also have a one-time blood draw for genetic testing, to look for a particular gene that is potentially associated with how we respond to pain medications and, potentially, with increased risk for addiction. After the surgery, patients will be assessed by the research team on day 1, week 1, week 4, week 8, and after 6 months with similar questionnaires to those that were completed pre-surgery. Patient satisfaction with their pre-surgical and post-surgical pain control will also be assessed by questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pain group | – | Other: post-surgical opioid use measured at 1 day and 1 week.post-surgical opioid use measured at 1 day and 1 week. |
| No chronic pain | – | Other: post-surgical opioid use measured at 1 day and 1 week.post-surgical opioid use measured at 1 day and 1 week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with and without chronic musculoskeletal pain or osteoarthritis pain that are having planned non-cancer related surgery
Key inclusion criteria (7 listed)
- Age 18-65
- With and without history of chronic muscle-skeletal pain *
- Scheduled to undergo elective abdominal surgery requiring overnight hospital admission
- Opioid naïve**
- Willing to comply with study procedures as outlined in the protocol
Key exclusion criteria (4 listed)
- Current use of opioids (includes ANY use in past 3 months)
- Cancer diagnosis
- Patient presenting the following documented conditions:
- Untreated psychosis Current suicidal ideation Current substance abuse
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 |
|---|---|---|
| post-surgical opioid use measured at 1 day and 1 week.Evaluation of intra-hospital perioperative opioid administration (including intraoperative opioids and Patient Controlled Analgesia (PCA) use). This endpoint is calculated as the total amount of morphine equivalents administered intraoperatively and in the first 24 hours after the end surgery (measured on postoperative day 1). 2) Opioid utilization after discharge from hospital (prescription refills and pills count at subsequent hospital visits). This endpoint is calculated as the total amount of morphine equivalents consumed in the first week after the surgery (measured at 1 week after surgery by electronic questionnaire and verified by direct pill count performed on occasion of the patient's postsurgical visit ). | Other | Chronic pain group, No chronic pain |
Primary outcome
Post-surgical opioid use
Time frame: 24 hours post-operatively
oral morphine equivalents (mg/day)
Post-surgical opioid use
Time frame: 1 week post-operatively
oral morphine equivalents (mg/day)
Results and safety
The study was stopped early (reason given: Insufficient patient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Laura Cavallone, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Opioid Use, run by Washington University School of Medicine 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Oct 2020. 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient patient enrollment.). 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?
Post-surgical opioid use (time frame: 24 hours post-operatively). 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 14 Oct 2020; AzTrials last refreshed its copy on 2 Nov 2026.