Healthy Volunteers for Analgesia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Pain Medicine at Centre Commons, Pittsburgh, PA
Analgesia+2 More
Medoc cutaneous probe - Behavioral
Eligibility
18 - 65
All Sexes
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Study Summary

The goal of this study is to measure the test retest reliability of offset analgesia (OA) and onset hyperalgesia (OH) across multiple study visits. OA and OH are quantitative sensory tests (QST) thought to measure how the brain modulates pain. This study will use a heat thermode to induce OA and OH in healthy, pain-free volunteers across 3 study visits. Additional QST measures and survey data relevant to pain modulation will be collected. This study lays the foundation required to use OA and OH as tools to measure pain modulation in clinical trials. Following their validation, we anticipate that OA and OH will serve as predictive and therapeutic biomarkers, which will aid both in the development of novel analgesics and in treatment selection leading to the personalization of pain management.

Eligible Conditions

  • Analgesia
  • Catastrophizing, Pain
  • Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 10 Secondary · Reporting Duration: 4 weeks after baseline

4 weeks after baseline
Pain intensity
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing
Questionnaire score- STAI Y1 post testing
Questionnaire score- Situational Pain Catastrophizing Scale post testing
4 weeks post baseline
Test retest reliability in brain region activation- QST (quantitative sensory tests)
Test retest reliability of offset analgesia and onset hyperalgesia
baseline
Differences in brain region activation- QST (quantitative sensory tests)
Differences in resting fNIRS signaling
Offset analgesia and onset hyperalgesia
Questionnaire score- Beck Depression Inventory-II (BDI-II)
Questionnaire score- Generalized Anxiety Disorder 2-item (GAD-2)
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2
Questionnaire score- Pain Catastrophizing Scale (PCS)
Questionnaire score- State Trait Anxiety Inventory (STAI) Y1-2

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Healthy Volunteers
1 of 1
Experimental Treatment

90 Total Participants · 1 Treatment Group

Primary Treatment: Healthy Volunteers · No Placebo Group · N/A

Healthy VolunteersExperimental Group · 3 Interventions: Medoc cutaneous probe, Quantitative sensory testing, Computer tasks · Intervention Types: Behavioral, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quantitative sensory testing
2016
Completed Phase 4
~550

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after baseline

Trial Background

Prof. Benedict Alter, Assistant Professor
Principal Investigator
University of Pittsburgh
Closest Location: UPMC Pain Medicine at Centre Commons · Pittsburgh, PA
Photo of Pittsburgh  1Photo of Pittsburgh  2Photo of Pittsburgh  3
2019First Recorded Clinical Trial
2 TrialsResearching Analgesia
1 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.