Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-25

Study Completion Date

2023-04-06

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain, Chronic Prescription Drug Abuse (Not Dependent)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with HICMP

Patients with PROMIS Pain Interference-6b scores one standard deviation above the national average will be categorized into this group.

No interventions assigned to this group

Patients without HICMP

Patients without PROMIS Pain Interference-6b scores one standard deviation above the national average will be categorized will be categorized into this group.

No interventions assigned to this group

Patients at risk for opioid abuse or misuse

The Opioid Risk Tool and PROMIS Short Form v1.0-Prescription Pain Medication Misuse will be used to categorize patients at risk.

No interventions assigned to this group

Patients not at risk for opioid abuse or misuse

The Opioid Risk Tool and PROMIS Short Form v1.0-Prescription Pain Medication Misuse will be used to categorize patients at risk.

No interventions assigned to this group

Eligibility Criteria

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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.