Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain

Genetic variability from epigenetic modification of genes related to pain physiology and opioid pharmacodynamics may influence susceptibility to high-impact chronic musculoskeletal pain, opioid efficacy, and vulnerability to opioid abuse. Exploring the role of epigenomics and opioid addiction may improve understanding and treatment of these complex multifactorial conditions and, potentially, reduce their development.

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Key information

Conditions

Pain, Chronic Chemically-Induced Disorders Chronic Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prescription Drug Abuse (Not Dependent) Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health of University of Florida, Gainesville, Florida, United States

About this study

Over 19 million adults suffer with chronic pain, which frequently limits life or work activities. Many of these patients are chronic prescription opioid consumers and may be at risk for opioid use disorder. Genetic variability of genes related to pain physiology and opioid pharmacodynamics may influence susceptibility to high-impact chronic musculoskeletal pain (HICMP), opioid efficacy, and vulnerability to opioid abuse. There is a paucity of research on the epigenetic profile of patients with HICMP and of those who fall in the spectrum between opioid addicted and opioid naive. Exploring the role of epigenomics in HICMP and opioid addiction may improve understanding and treatment of these complex multifactorial conditions and, potentially, reduce development.

The long-term goal is to create a profile of genetic and psychosocial risk factors for identifying patients susceptible to HICMP and opioid abuse. The objective of this pilot study is to gather preliminary data on the association of epigenetic modification of genes with HICMP and prescription opioid abuse.The study team propose to compare COMT and OPRM1 DNA methylation patterns in patients with HICMP (Group 1) to those without HICMP (Group 2).The investigators will also correlate OPRM1 DNA methylation patterns with the likelihood of misuse and abuse in chronic opioid consumers. It is hypothesized: (1) the promoter region of the COMT and OPRM1 genes will be hypo- and hyper-methylated, respectively, in Group 1 compared to Group 2; and (2) the OPRM1 gene in patients at high risk for opioid misuse and abuse will be hyper-methylated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients age ≥18 years with chronic musculoskeletal pain (pain present for 3 or more months) treated with prescription opioids on most days in the past 3 months.

Exclusion criteria

Patients who are non-English speaking,
Patients who are incarcerated
Patients who are unable to provide consent will be excluded.

Treatment and study plan

Primary outcomes

PROMIS Pain Interference 6b

Time frame: Baseline

Symptom assessment tool measures six items on 5-point scales for pain interference on aspects of daily life. The higher the total score, the more severe the symptom.
Opioid Risk Tool

Time frame: Baseline

Prescription opioid abuse or misuse will be measured using the Opioid Risk Tool. This tool should be administered to patients upon an initial visit prior to beginning opioid therapy for pain management. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse.
PROMIS Short Form v1.0-Prescription Pain Medication Misuse

Time frame: Baseline

Seven question survey concerning prescription pain medication use within the last 3 months. Self reported answers ranging 1-5; with 1 being 'never' to 5 being 'almost always.' Prescription opioid abuse or misuse will be measured using the PROMIS Short Form v1.0-Prescription Pain Medication Misuse. Patients with PPMM scores of 60 or more will be considered high risk for opioid misuse or abuse.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Florida Medical Malpractice Joint Underwriting Association

Registry information

Acronym: LEAP

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: May 13, 2019
Registry last updated: Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed