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NCT03897998 · ClinicalTrials.gov registry record · Phase 2

Neural Correlates of Hypoalgesia Driven by Observation

A Phase 2 study of Pain and Virtual Reality, sponsored by University of Maryland, Baltimore.

Recruiting
Registry status
Phase 2
Development phase
182
Enrollment target
1
Study location

NCT03897998 is a Phase 2 study of Pain and Virtual Reality that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 182 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03897998, a Phase 2 study of Pain and Virtual Reality, is actively recruiting participants, sponsored by University of Maryland, Baltimore.

RECRUITING
Registry status
Phase 2
Development phase
182 participants
Enrollment target
1
Study location

Study Summary

Placebo effects held an ambivalent place in health care for at least two centuries. On the one hand, placebos are traditionally used as controls in clinical trials to correct for biases and the placebo response is viewed as an effect to be factored out in order to isolate and accurately measure the effects of the treatment. On the other hand, there is scientific evidence that placebo effects represent fascinating psychoneurobiological events involving the contribution of distinct central nervous as well as peripheral physiological mechanisms that influence pain perception and clinical pain symptoms and substantially modulate the response to pain therapeutics. Therefore, placebo effects have shifted from being a challenge for clinical trials to a resource to trigger the reduction of pain based on endogenous mechanisms that can be activated in the brain to promote hypolagesia, self-healing, and well-being. This is relevant in acute pain settings given that chronic opioid users die within approximately 2.5 years of being prescribed their first opioid medication to treat acute pain. The overall hypothesis is that observational learning influences neural pain modulation and cognition systems, including processes associated with mentalizing (the ability to cognitively understand mental states of others), empathy (the ability to share an emotional experience), and expectancy (the anticipation of a benefit). The objective is to determine the brain mechanisms of observationally-induced analgesia using brain mapping approaches that target changes in blood oxygenation and oscillatory activity in the brain, thus enabling investigators to draw inferences about the localization and extent of neurobiological activation underlying hypoalgesia driven by observation. Therefore, the investigators designed innovative experiments using pharmacological fMRI, EEG, and combined EEG-fMRI measurements.

Interventions

  • OTHER Saline
  • DRUG Naloxone

Study Locations (1)

Maryland

  • University of Maryland - Baltimore

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2021-11-01
Est. Completion 2025-12-31
Phase Phase 2

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT03897998

The ClinicalTrials.gov registry entry for NCT03897998 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (40% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.

NCT03897998 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03897998 about?

NCT03897998 is a clinical study titled "Neural Correlates of Hypoalgesia Driven by Observation". Placebo effects held an ambivalent place in health care for at least two centuries. On the one hand, placebos are traditionally used as controls in clinical trials to correct for biases and the placebo response is viewed as an effect to be factored out in order to isolate and accurately measure the ...

What is the current status of trial NCT03897998?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2021-11-01. Estimated completion is 2025-12-31.

What conditions does trial NCT03897998 study?

This clinical trial studies the following conditions: Pain, Virtual Reality, Placebo.

What interventions are being tested in trial NCT03897998?

The interventions under investigation include: Saline (OTHER), Naloxone (DRUG).

Who is sponsoring clinical trial NCT03897998?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03897998 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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