Vasopressin and Pain Perception in the Brain

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT03446456
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Acute Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Arginine vasopressin — DRUG
    Intranasal vasopressin will be administered shortly before the fMRI experiment.
  • Saline — OTHER
    Intranasal saline will serve as a placebo for participants in the Saline Arm
  • Observational learning — BEHAVIORAL
    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 — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 26, 2018
Start date
Sep 17, 2018
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.).

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

Locations (1)

FacilityCityStateZIPSite coordinators
Luana CollocaBaltimoreMaryland21201-1512
Luana Colloca, MD, PhD, MS
301-364-8089

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