Recruiting
Phase 1
Phase 2

Vasopressin

Sponsor:

University of Maryland, Baltimore

Code:

NCT03446456

Conditions

Acute Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Arginine vasopressin

Saline

Observational learning

fMRI data aquisition

Study Details

Brief 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.

Conditions

Acute Pain

Study ID

NCT03446456

Start date

Sep 17, 2018

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age ( 18-55 years old)
  • English speaker (written and spoken)

Exclusion Criteria:

  • Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, degenerative neuromuscular disease, history of cancer within past 3 years
  • Any history of chronic pain disorder or currently in pain
  • Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, mania, autism) and /or psychiatric condition leading to treatment and/or hospitalization within the last 3 years.
  • Family (first degree) history of mania, schizophrenia, or other psychoses
  • Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
  • Pregnancy or breast feeding
  • Color-blindness
  • Impaired, uncorrected hearing
  • History of angioedema
  • High blood pressure (above 140 mmHg) or symptomatic low blood pressure
  • History of fainting
  • Left handed
  • Allergies or sensitivities to creams, lotions or food coloring
  • Any non-organic implant or any non-removable metal device (e.g. pacemaker, cochlear implants, stents, surgical clips, non-removable piercings)
  • Any prior eye injury or the potential of a foreign body in the eye (e.g. worked in metal fields)Persisting functional impairment due to a head trauma
  • Fear of closed spaces
  • Any other contraindications for MRI (e.g. large tattoos on head and neck)
  • Previously participated in a "Pain Perception in the Brain" Study
  • Failed drug test (testing for opiates, cocaine, methamphetamines, amphetamines and THC)

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Saline

Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.

Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.

experimental: Arginine vasopressin

Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).

Interventions

Arginine vasopressin

Intranasal vasopressin will be administered shortly before the fMRI experiment.

Saline

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

Observational learning

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 aquisition

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.

Primary outcome measure

  • Change in BOLD Singal in Supplementary Motor Area Compared to Whole Brain Average During the Painful Stimulation [ Time Frame: Day 2, the average of 24 trials of painful stimulations with each stimulation lasting 20 seconds ]

Central Contacts and Locations

Central contacts

Locations

Luana Colloca

Recruiting

Baltimore, Maryland, United States, 21201-1512

Contacts

Luana Colloca, MD, PhD, MS

301-364-8089colloca@umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Magnetic Resonance Imaging
  • Healthy Volunteers
  • Arginine Vasopressin
  • Antidiuretic Hormone
  • Analgesia
  • Social Behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-09.