Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain

Pain, Chronic Clinical Trial

— LEAP  

Official title:

Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947749
• Other study ID #: IRB201901297
• Status: Completed
• Start date: September 25, 2019
• Est. completion date: April 6, 2023

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: April 6, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Opioid-Related Disorders
• Pain, Chronic
• Prescription Drug Abuse (Not Dependent)
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	UF Health of University of Florida	Gainesville	Florida
United States	UF Health - Jacksonville	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Florida Medical Malpractice Joint Underwriting Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Pain Interference 6b	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.	Baseline
Primary	Opioid Risk Tool	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.	Baseline
Primary	PROMIS Short Form v1.0-Prescription Pain Medication Misuse	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.	Baseline