Pain, ChronicLEAPNCT03947749
Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
An observational study of Pain, Chronic and Prescription Drug Abuse (Not Dependent), run by University of Florida at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic, Prescription Drug Abuse (Not Dependent)
- How many people
- 275 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Sep 2019to 6 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who are non-English speaking,
- Patients who are incarcerated
- Patients who are unable to provide consent will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health of University of Florida
Gainesville, Florida, 32610
UF Health - Jacksonville
Jacksonville, Florida, 32008
About this study
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.
Read the 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.
- Medical subject headings
- Chronic Pain, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start25 Sep 2019
- Primary completion5 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Medical Malpractice Joint Underwriting Association
- Responsible party
- Sponsor
- Investigators
- Sophia Sheikh, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947749
- Sponsor's protocol ID
- IRB201901297
- Acronym
- LEAP
- Status last verified
- Aug 2023
- First submitted
- 9 May 2019
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT03947749
- Acronym / sponsor ID
- LEAP / IRB201901297
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Florida Medical Malpractice Joint Underwriting Association
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who are non-English speaking,
- Patients who are incarcerated
- Patients who are unable to provide consent will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Sheikh, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Prescription Drug Abuse (Not Dependent), run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pain Interference 6b (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.