Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05304403

Conditions

Chronic Pain

Opioid Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05304403

Start date

Apr 1, 2022

Status verified date

Jul, 2023

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Microbiome patterns [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2023-07-27.