Chronic PainNCT05304403
The Association of Microbiome Patterns With Chronic Opioid Use
An observational study of Chronic Pain and Opioid Use, run by University of California, San Diego at 1 site in United States.
Trial summary
The United States is in the midst of an opioid epidemic, with the number of opioid-related deaths having risen six-fold since 1999. Chronic pain imposes a tremendous economic burden of up to US$635 billion per year in terms of direct costs (such as the costs of treatment) and indirect costs (such as lost productivity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic pain patients will be identified at scheduled appointments with their chronic pain physician at UCSD. The investigators will recruit any patient eligible based on the above inclusion and exclusion criteria.
Who may be able to join
- Adult patients (age greater than or equal to 18 years old) on chronic opioids (use of any amount of opioids for at least 3 months for a chronic pain condition)
Who cannot join
- No recent surgery within the last 3 months
- No antibiotic use within the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92037
Rodney A Gabriel, MD, 858-663-7747, ragabriel@health.ucsd.edu
About this study
Official title: Identifying Associations in Gut Microbiome Patterns in Patients With Chronic Opioid Use Compared to Healthy Controls
The United States is in the midst of an opioid epidemic, with the number of opioid-related deaths having risen six-fold since 1999. Chronic pain imposes a tremendous economic burden of up to US$635 billion per year in terms of direct costs (such as the costs of treatment) and indirect costs (such as lost productivity and time away from work). We need to better understand individual characteristics that may put patients at risk for chronic opioid use. Recently, the relationship between gut microbiome and diseases of the central and peripheral nervous systems has received increasing attention. New evidence suggests that gut microbiota may also play a critical role in many types of chronic pain, including inflammatory pain, neuropathic pain, and opioid tolerance. Many signaling molecules derived from gut microbiota, such as pathogen-associated molecular patterns, metabolites, and neurotransmitters, act on receptors that regulate the peripheral and central sensitization, which in turn mediate the development of chronic pain. Gut microbiota-derived mediators serve as critical modulators for the induction of peripheral sensitization, directly or indirectly regulating the excitability of primary nociceptive neurons. Given the strong evidence supporting gut microbiome's involvement in pain pathways, there is a need to develop studies that characterize the differences in gut microbiome between chronic pain patients requiring opioids versus healthy controls. The objective of this proposal is to perform a pilot study measuring the predictive ability of the gut microbiome with chronic opioid use - this will then lay the groundwork to adequately power a larger funded prospective study.
Read the detailed description
The investigators hypothesize that there will be distinct characteristics in the composition of the microbiome in chronic opioid users versus healthy controls (controls identified from national database). Consenting patients (n~ 100) - who will be identified in the institution's chronic pain clinic - will provide fecal samples for microbiome composition analysis. In addition, additional data will be collected including patient age, sex, body mass index, comorbidities, opioid dosing/frequency, pain scores, and pain characteristics. This additional information will be ascertained by a basic intake form and the Brief Pain Inventory. The investigators have access to the Human Microbiome Project Database and will obtain matched samples to represent healthy controls (retrospective publicly available database).
Consent: After pre-screening eligible patients from the chronic pain clinic, patients will either be consented in person (at their clinic visit), which in that case they will fill out the intake surveys in-person and be provided to take home a microbiome kit. The kit will require patients to swab their stool. This will then be mailed back to the invsestigators. All shipping will be pre-paid by the research team. Patients may also be consented via the phone, in which case, the consent form will be signed via HIPAA-secure DocuSign. Surveys will then be sent to patient via email through Redcap services. The microbiome kit will be mailed to the patient's residence.
Statistical Analysis: The microbiome data is highly dimensional and will therefore be analyzed using several approaches. Compositional data will be assessed using the QIIME2 pipeline where alpha and beta diversity measures, and taxonomic relative abundances will be compared using standard non-parametric and linear models (Wilcoxon Rank-Sum and Kruskal-Wallis tests are most common based on standard microbiome data). Secondary analyses will include comparing microbiome compositions among subsets of chronic opioid users based on their overall daily dosing.
Sample Size Calculation: As this is a pilot study, the investigators did not perform a power analysis. Rather, they will recruit 100 subjects. The results from this study will be used to help design and power a larger funded prospective study.
- Conditions
- Chronic Pain, Opioid Use
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Opioid User | Patients identified to have chronic opioid use (identified in chronic pain clinic) | |
| Healthy Control | These patients will not be actively recruited in this study. The investigators will use national microbiome dataset as a comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome patterns
Identify patterns in microbiome between chronic opioid users and healthy controls
Measured: 6 months
Secondary outcomes (1)
Microbiome patterns
Identify patterns in microbiome patterns between high opioid users (defined as greater than or equal to the median daily morphine equivalents) versus low opioid users (less than the median morphine equivalents in the group)
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodney Gabriel, University of California, San Diego
- Investigators
- Rodney Gabriel, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304403
- Sponsor's protocol ID
- 801745
- Status last verified
- Jul 2023
- First submitted
- 22 Mar 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Associations in Gut Microbiome Patterns in Patients With Chronic Opioid Use Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT05304403
- Acronym / sponsor ID
- 801745
- Conditions
- Chronic Pain, Opioid Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 31 Mar 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.
The United States is in the midst of an opioid epidemic, with the number of opioid-related deaths having risen six-fold since 1999. Chronic pain imposes a tremendous economic burden of up to US$635 billion per year in terms of direct costs (such as the costs of treatment) and indirect costs (such as lost productivity and time away from work). We need to better understand individual characteristics that may put patients at risk for chronic opioid use. Recently, the relationship between gut microbiome and diseases of the central and peripheral nervous systems has received increasing attention. New evidence suggests that gut microbiota may also play a critical role in many types of chronic pain, including inflammatory pain, neuropathic pain, and opioid tolerance. Many signaling molecules derived from gut microbiota, such as pathogen-associated molecular patterns, metabolites, and neurotransmitters, act on receptors that regulate the peripheral and central sensitization, which in turn mediate the development of chronic pain. Gut microbiota-derived mediators serve as critical modulators for the induction of peripheral sensitization, directly or indirectly regulating the excitability of primary nociceptive neurons. Given the strong evidence supporting gut microbiome's involvement in pain pathways, there is a need to develop studies that characterize the differences in gut microbiome between chronic pain patients requiring opioids versus healthy controls. The objective of this proposal is to perform a pilot study measuring the predictive ability of the gut microbiome with chronic opioid use - this will then lay the groundwork to adequately power a larger funded prospective study.
Detailed description
The investigators hypothesize that there will be distinct characteristics in the composition of the microbiome in chronic opioid users versus healthy controls (controls identified from national database). Consenting patients (n~ 100) - who will be identified in the institution's chronic pain clinic - will provide fecal samples for microbiome composition analysis. In addition, additional data will be collected including patient age, sex, body mass index, comorbidities, opioid dosing/frequency, pain scores, and pain characteristics. This additional information will be ascertained by a basic intake form and the Brief Pain Inventory. The investigators have access to the Human Microbiome Project Database and will obtain matched samples to represent healthy controls (retrospective publicly available database).
Consent: After pre-screening eligible patients from the chronic pain clinic, patients will either be consented in person (at their clinic visit), which in that case they will fill out the intake surveys in-person and be provided to take home a microbiome kit. The kit will require patients to swab their stool. This will then be mailed back to the invsestigators. All shipping will be pre-paid by the research team. Patients may also be consented via the phone, in which case, the consent form will be signed via HIPAA-secure DocuSign. Surveys will then be sent to patient via email through Redcap services. The microbiome kit will be mailed to the patient's residence.
Statistical Analysis: The microbiome data is highly dimensional and will therefore be analyzed using several approaches. Compositional data will be assessed using the QIIME2 pipeline where alpha and beta diversity measures, and taxonomic relative abundances will be compared using standard non-parametric and linear models (Wilcoxon Rank-Sum and Kruskal-Wallis tests are most common based on standard microbiome data). Secondary analyses will include comparing microbiome compositions among subsets of chronic opioid users based on their overall daily dosing.
Sample Size Calculation: As this is a pilot study, the investigators did not perform a power analysis. Rather, they will recruit 100 subjects. The results from this study will be used to help design and power a larger funded prospective study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Opioid User | – | –Patients identified to have chronic opioid use (identified in chronic pain clinic) |
| Healthy Control | – | –These patients will not be actively recruited in this study. The investigators will use national microbiome dataset as a comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic pain patients will be identified at scheduled appointments with their chronic pain physician at UCSD. The investigators will recruit any patient eligible based on the above inclusion and exclusion criteria.
Key inclusion criteria (1 listed)
- Adult patients (age greater than or equal to 18 years old) on chronic opioids (use of any amount of opioids for at least 3 months for a chronic pain condition)
Key exclusion criteria (2 listed)
- No recent surgery within the last 3 months
- No antibiotic use within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome patterns
Time frame: 6 months
Identify patterns in microbiome between chronic opioid users and healthy controls
1 secondary outcome
Microbiome patterns
Time frame: 0 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided. available upon reasonable request
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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.
Rodney Gabriel, MD principal investigator
University of California, San Diego
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 Chronic Pain and Opioid Use, run by University of California, San Diego 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 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.
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?
Contact Rodney A Gabriel, MD (8582493660, ragabriel@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome patterns (time frame: 6 months). 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 27 Jul 2023.