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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 below
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I am between 18 and 75 years old.
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I have been experiencing chronic pain for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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
246 Previous Clinical Trials
56,757 Total Patients Enrolled
Denise Wilkes, MD-PhDPrincipal InvestigatorUniversity of Texas
1 Previous Clinical Trials
96 Total Patients Enrolled

Media Library

taper Clinical Trial Eligibility Overview. Trial Name: NCT03375216 — N/A
Analgesic Dependence Research Study Groups: non taper intrathecal, non opioids, taper, non taper systemic <90, non taper systemic >90
Analgesic Dependence Clinical Trial 2023: taper Highlights & Side Effects. Trial Name: NCT03375216 — N/A
taper 2023 Treatment Timeline for Medical Study. Trial Name: NCT03375216 — N/A
~6 spots leftby Jun 2025
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