Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain (LEAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03947749
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Florida Medical Malpractice Joint Underwriting Association
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease
Pain, Chronic Prescription Drug Abuse (Not Dependent)

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Mouthwash samples will be collected in all enrolled subjects


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947749


Contacts
Layout table for location contacts
Contact: Sophia Sheikh, MD 904-244-4986 Sophia.Sheikh@jax.ufl.edu
Contact: Phyllis Hendry, MD 904-244-4986 Phyllis.Hendry@jax.ufl.edu

Locations
Layout table for location information
United States, Florida
UF Health of University of Florida Recruiting
Gainesville, Florida, United States, 32610
UF Health - Jacksonville Recruiting
Jacksonville, Florida, United States, 32008
Sponsors and Collaborators
University of Florida
Florida Medical Malpractice Joint Underwriting Association
Investigators
Layout table for investigator information
Principal Investigator: Sophia Sheikh, MD University of Florida

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03947749     History of Changes
Other Study ID Numbers: IRB201901297
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Musculoskeletal Pain
Chronic Pain
Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents