CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 40 enrolled
Drug / intervention
Arginine vasopressin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03446456
NCT03446456Phase 2Active

The Influence of Vasopressin on Observational Learning of Placebo Analgesia

University of Maryland, Baltimore·interventional·Posted Feb 26, 2018·Updated May 20, 2025

In Brief

A Phase 2 clinical trial evaluating Arginine vasopressin, Saline, and 2 other interventions for Acute Pain. Active but no longer recruiting, targeting 40 participants across 1 site.

Detailed 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. The comparison of the vasopressin group and the saline group will allow us to investigate how vasopressin influences behavioral effects of observational learning on pain perception as well as its effect on the neural processing of observational learning. A better understanding of how the human brain processes observationally-induced analgesia would allow us to improve the therapeutic context of pain treatments by increasing the contextual factors which help patients cope with pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
2018201920202021202220232024202520262027
First PostedFeb 26, 2018
Enrollment StartSep 17, 2018
Primary CompletionJun 30, 2026
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 8.3 years ago

Interventions

Arginine vasopressindrug

Intranasal vasopressin will be administered shortly before the fMRI experiment.

Salineother

Intranasal saline will serve as a placebo for participants in the Saline Arm

Observational learningbehavioral

During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.

fMRI data aquisitionother

All participants from the intranasal vasopressin and intranasal saline groups will go through a fMRI data acquisition to obtain the brain structural, brain resting-states and functional MRI scans.