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Opioid Management for Chronic Pain
N/A
Waitlist Available
Led By Denise Wilkes, MD-PhD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient age between 18 and 75
History of chronic pain for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study the effects of chronic opioid treatment and tapering on sensation in chronic pain patients and normal volunteers.
Who is the study for?
This trial is for adults aged 18-75 with chronic pain lasting at least 3 months. It's open to those on opioid therapy or selected for opioid tapering by their doctors, and who can understand and consent to the study. People with cancer pain, unstable health conditions like recent heart attacks or uncontrolled diabetes, pregnant women, recent or upcoming surgery patients, steroid users, and those with a substance abuse history within five years are excluded.Check my eligibility
What is being tested?
The study examines how chronic opioid use and gradual reduction of opioids (tapering) affect sensation in patients. Participants will undergo sensory tests involving heat, cold, pressure sensations as well as complete PROMIS surveys designed to measure patient-reported outcomes.See study design
What are the potential side effects?
Since this trial involves non-invasive sensory testing procedures and surveys rather than drug interventions, side effects are minimal but may include temporary discomfort from the sensory tests such as mild pain from pressure or temperature changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I have been experiencing chronic pain for at least 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cold threshold measurements
Heat threshold measurements
Pressure threshold measurements
Secondary outcome measures
PROMIS surveys
Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: taperActive Control2 Interventions
participants undergoing a taper as directed by their pain physician. Interventions include sensory testing ( heat, cold, and pressure) and PROMIS surveys.
Group II: non taper intrathecalPlacebo Group2 Interventions
Participants on intrathecal therapy and no taper
Group III: non opioidsPlacebo Group2 Interventions
Participants on non-opioid therapy will undergo behavioral tests and PROMIS surveys
Group IV: non taper systemic <90Placebo Group2 Interventions
participants on systemic opioids < 90 MEDD (morphine equivalent daily dose) and no taper
Group V: non taper systemic >90Placebo Group2 Interventions
participants on systemic opioids > 90 MEDD and no taper
Find a Location
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,555 Total Patients Enrolled
Denise Wilkes, MD-PhDPrincipal InvestigatorUniversity of Texas
1 Previous Clinical Trials
96 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience pain due to my cancer.I am currently taking steroids that affect my whole body.You are not able to answer survey questions properly.I do not have any uncontrolled health conditions like recent heart attacks, autoimmune diseases, or severe diabetes.You have a history of using drugs or alcohol in the past 5 years.I may or may not be taking opioid pain medication.I had surgery within the last month.I am scheduled for surgery within the next six months.I am between 18 and 75 years old.I have been experiencing chronic pain for at least 3 months.My doctor has chosen to reduce my opioid medication.
Research Study Groups:
This trial has the following groups:- Group 1: non taper intrathecal
- Group 2: non opioids
- Group 3: taper
- Group 4: non taper systemic <90
- Group 5: non taper systemic >90
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research undertaking seeking out participants aged 45 and up?
"This clinical trial is only available to participants aged between 18 and 75. By contrast, there are 108 studies for those under the age of majority and 606 trials targeting senior citizens on the same platform."
Answered by AI
How many participants are in this clinical research project?
"Affirmative. The clinicaltrials.gov page lists this trial as actively recruiting patients, having been initially posted on December 22nd 2017 and last updated on December 20th 2021. Currently 90 individuals are needed for the study across 1 site."
Answered by AI
Is it possible to become part of this clinical research?
"This medical experiment seeks 90 individuals aged 18 to 75 with persistent pain. Essential criteria include a record of chronic agony for at least 3 months, potential enrollees may have been advised by their physician to reduce opioid therapy, and participants can be on opioids or not."
Answered by AI
Are there open slots for volunteers in this clinical trial?
"As evidenced by clinicaltrials.gov, this medical trial is at present seeking out participants. This research project was first announced on December 22nd 2017 and it's most recent update took place on December 20th 2021."
Answered by AI
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