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NCT03446456 · ClinicalTrials.gov registry record · Phase 1
Vasopressin and Pain Perception in the Brain
A Phase 1 study of Acute Pain, sponsored by University of Maryland, Baltimore.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03446456: Active Phase 1 study of Acute Pain, sponsored by University of Maryland, Baltimore.
NCT03446456 is a Phase 1 study of Acute Pain that is active but no longer recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 40 participants, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03446456, a Phase 1 study of Acute Pain, is active but no longer recruiting, sponsored by University of Maryland, Baltimore.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The feeling of pain is not just a sensory experience, but is also influenced by emotions, beliefs and expectations, making pain a highly subjective experience. This is evident in clinical practice, where the behavior of the physician and the treatment context can strongly influence the pain experience of patients. Research has shown that patients' expectation that a treatment will reduce pain influences individual perception of pain, even if the treatment has no active ingredient. The expectancy-induced analgesia emerges due to a modulation of the individual pain experience of patients by an engagement of endogenous inhibitory systems in the central nervous system. The development of expectancy-induced analgesia can be generated in several ways. The investigators have previously demonstrated that social information and observational learning (e.g. the patient observes analgesia in another person receiving a treatment) can lead to expectancy-induced analgesia and pain reduction. However, the neural mechanisms (mechanisms in the brain) of how these expectancies are acquired and the neural mechanisms of analgesia induced by observational learning are unknown. The investigators recently established a procedure to investigate neural mechanisms of observational learning in placebo analgesia. Here the investigators propose to investigate the influence of vasopressin, a neurotransmitter that is important for social interaction, on observational learning. The investigators will use functional magnetic resonance imaging (fMRI), a non-invasive method, to investigate neural activity in humans. Participants will either receive vasopressin or saline with a nasal spray. During fMRI scanning, participants will then undergo an observational learning phase, where the study participants will learn the experience of analgesia in another person through a video, and a testing phase, where participants will perceive painful stimulations with the same cues as the observational phase. Th
Primary Outcome
Blood oxygenation level dependent (BOLD) responses will allow the identification of relative activation/deactivation in the brain as a result of events (e.g. painful stimulations) that will be given during the experiment. Changes in the Percentage of BOLD signal are calculated as the BOLD signal in the right supplementary motor area during the 20-second heat pain divided by the whole-brain average BOLD signal during that 20-second heat pain.
Conditions Studied
Interventions
- OTHER Saline
- DRUG Arginine vasopressin
- BEHAVIORAL Observational learning
- OTHER fMRI data aquisition
Study Locations (1)
Maryland
- Luana Colloca - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03446456 still lists
NCT03446456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 4 interventions - of which Saline is the first listed.
NCT03446456 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03446456 about?
NCT03446456 is a clinical study titled "Vasopressin and Pain Perception in the Brain". The feeling of pain is not just a sensory experience, but is also influenced by emotions, beliefs and expectations, making pain a highly subjective experience. This is evident in clinical practice, where the behavior of the physician and the treatment context can strongly influence the pain experien...
What is the current status of trial NCT03446456?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-09-17. Estimated completion is 2026-12-31.
What conditions does trial NCT03446456 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT03446456?
The interventions under investigation include: Saline (OTHER), Arginine vasopressin (DRUG), Observational learning (BEHAVIORAL), fMRI data aquisition (OTHER).
Who is sponsoring clinical trial NCT03446456?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03446456 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03446456's enrollment target sits among peer trials
40 42nd of 50 higher than 9 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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