N/A
N=7
Opioid Taper Study
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03912298 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Pain Perception Measured Using the Cold-pressor Test (CPT) — 24.01; 42.02 seconds
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Opioid Taper Pain perception (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Perception Measured Using the Cold-pressor Test (CPT) |
24.01; 42.02 | — |
| PRIMARY Conditioned Pain Modulation Measured Using the Quantitative Sensory Testing (QST) |
-0.14; -0.40 | — |
Summary
The purpose of this study is to determine the effect of opioid taper on pain sensitivity in patients with chronic pain. In a well-characterized sample of men and women with chronic neuropathic pain on high-dose opioid therapy, experimental pain responses (cold-pressor, quantitative sensory testing) will be serially described over the course of and following an individualized opioid taper. In addition, functional improvements and subject-level predictors of response will be described.
Eligibility Criteria
Inclusion Criteria
- between ages of 21-70;
- documented chronic neuropathic non-malignant pain condition of at least one year duration;
- on >100mg/day MED for at least 6 months;
- have fully engaged in all prescribed non-opioid pain management treatments;
- willing to undergo prescribed opioid taper;
- otherwise in good physical and mental health, or in the care of a physician who is willing to take responsibility for such treatment;
- able to understand the purpose and instructions of the study, and provide informed consent as approved by the University of Pennsylvania IRB.
Exclusion Criteria
- meet diagnostic criteria for an active substance use disorder other than nicotine;
- be acutely psychotic, severely depressed, and/or in need of inpatient psychiatric treatment,
- have a neurological or psychiatric illness that would affect pain responses, including anxiety disorders;
- have a history of heart disease, stroke, or a pacemaker or uncontrolled high blood pressure. Good cardiovascular health is stipulated to ensure subjects can tolerate the sympathetic nervous system responses associated with the pain induction procedures.
Data sourced from ClinicalTrials.gov (NCT03912298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.