Linking Epigenomics With Prescription Opioid Abuse & High Impact

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03947749
Study type	Observational
Source	University of Florida
Contact
Status	Completed
Phase
Start date	September 25, 2019
Completion date	April 6, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05452499` - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae	N/A
Recruiting	`NCT05037682` - Pain and Opioid Management in Older Adults	N/A
Completed	`NCT04080037` - Assessing Opioid Care Practices Using CPV Patient Simulation Modules	N/A
Recruiting	`NCT05382962` - iCanCope With Post-Operative Pain (iCanCope PostOp)	N/A
Recruiting	`NCT04285112` - SPRINT: Signature for Pain Recovery IN Teens
Active, not recruiting	`NCT04850079` - EHR Precision Drug Treatment in Neonates
Completed	`NCT03272139` - Interscalene Block Versus Superior Trunk Block	Phase 4
Completed	`NCT03271151` - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty	Phase 4
Completed	`NCT03886142` - Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis	N/A
Recruiting	`NCT05761392` - APP-based Precise Management System of Chronic Intractable Pain	N/A
Recruiting	`NCT05877157` - Pain AND Opioids After Surgery
Completed	`NCT03280017` - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain	Phase 4
Recruiting	`NCT04874038` - Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)	Phase 3
Completed	`NCT04280796` - Changes in Affective Pain Processing in Human Volunteers	N/A
Withdrawn	`NCT05125978` - Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain	Phase 2
Not yet recruiting	`NCT04328805` - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.	Phase 4
Completed	`NCT04976738` - A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain	Phase 1/Phase 2
Completed	`NCT04089618` - Meditation Based Lifestyle Modification in Chronic Pain	N/A
Recruiting	`NCT05699837` - Alpha Entrainment for Pain and Sleep (Extension)	N/A
Enrolling by invitation	`NCT05047120` - Hypnotic Cognitive Therapy Reduce Acute & Chronic SCI Pain in Inpatient Rehabilitation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms