The Association of Microbiome Patterns With Chronic Opioid Use

NCT05304403 | Unknown

• 1 other identifier: 801745
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Microbiome patterns

  Identify patterns in microbiome between chronic opioid users and healthy controls

  6 months

Secondary Outcomes (1)

• Microbiome patterns

  0 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fecal sample

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodney Gabriel, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodney A Gabriel, MD

CONTACT

8582493660; ragabriel@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)