The Association of Microbiome Patterns With Chronic Opioid Use

NCT ID: NCT05304403

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-06-01

Brief 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 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.

Conditions

Chronic Pain; Opioid Use

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic Opioid User

Patients identified to have chronic opioid use (identified in chronic pain clinic)

No interventions assigned to this group

Healthy Control

These patients will not be actively recruited in this study. The investigators will use national microbiome dataset as a comparison.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• No recent surgery within the last 3 months
• No antibiotic use within the last 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Rodney Gabriel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodney Gabriel, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California San Diego

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rodney A Gabriel, MD

Role: CONTACT

ragabriel@health.ucsd.edu

8582493660

Facility Contacts

Rodney A Gabriel, MD

Role: primary

ragabriel@health.ucsd.edu

858-663-7747

Other Identifiers

801745

Identifier Type: -

Identifier Source: org_study_id