Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain

NCT03947749 | Completed

• 1 other identifier: IRB201901297
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Chronic; Prescription Drug Abuse (Not Dependent)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (4)

Patients with HICMP

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

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• Florida Medical Malpractice Joint Underwriting Association: collaborator

Study Sites (2)

UF Health of University of Florida

Gainesville, Florida, 32610, United States

Location

UF Health - Jacksonville

Jacksonville, Florida, 32008, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mouthwash samples will be collected in all enrolled subjects

MeSH Terms

Conditions

Chronic Pain; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sophia Sheikh, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: September 25, 2019
• Primary Completion: April 5, 2023
• Study Completion: April 6, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)