Clinical trial NCT03947749: Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
Official title: Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Prescription Drug Abuse (Not Dependent)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Florida Medical Malpractice Joint Underwriting Association
First posted: 2019-05-13
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be adult patients with chronic musculoskeletal pain (pain present for 3 or more months) treated with prescription opioids on most days in the past 3 months.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PROMIS Pain Interference 6b
timeFrame: Baseline
measure: Opioid Risk Tool
timeFrame: Baseline
measure: PROMIS Short Form v1.0-Prescription Pain Medication Misuse
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health of University of Florida
state: Florida
city: Jacksonville
country: United States
facility: UF Health - Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Sophia Sheikh, MD
role: PRINCIPAL_INVESTIGATOR
References: