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Vasopressin and Pain Perception in the Brain

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ClinicalTrials.gov Identifier: NCT03446456
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Luana Colloca, University of Maryland

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.


Condition or disease Intervention/treatment Phase
ADH Arginine Vasopressin Antidiuretic Hormone Placebo Analgesia Social Behavior Drug: Arginine vasopressin Other: Saline Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This experiment has a between-subjects design. Participants will be randomized into two groups: AVP and control. Both the experimenter and participant will be blinded to the group allocation. Participants have 50%/50% chance of being placed in either group. Participants in the AVP group will receive intranasal AVP and the participants in the control group will receive intranasal saline before the fMRI experiment. The experiment in the fMRI scanner is divided into two phases: an observational phase in which participants will observe a video of a demonstrator experiencing analgesia and a testing phase in which study participants will receive heat pain to investigate how their pain perception. During both phases there will be a placebo condition (pain with the expectation of having received a treatment) and a control condition (pain without the expectation of having received a treatment). All participants will complete both phases, including the observational and testing phase.
Masking: Double (Participant, Investigator)
Masking Description: Randomization will be performed/maintained by the University of Maryland Medical Center Pharmacy. Blind will only be broken in case of a potential medical emergency during the experiment.
Primary Purpose: Basic Science
Official Title: The Influence of Vasopressin on Observational Learning of Placebo Analgesia
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other: Saline
Intranasal saline will serve as a placebo for participants in the Saline Arm
Other Name: Placebo

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.).

A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.

Drug: Arginine vasopressin
Intranasal vasopressin will be administered shortly before the fMRI experiment.
Other Name: Arg8-vasopressin synthetic




Primary Outcome Measures :
  1. Neural outcome [ Time Frame: Day 2 ]
    Blood oxygenation level dependent (BOLD) responses will allow the identification of relative activation/deactivation in the brain as result of events (e.g. painful stimulations) that will be given during the experiment.


Secondary Outcome Measures :
  1. Pain ratings [ Time Frame: Days 1 (calibration) and 2 (test) ]
    Participants will provide their pain on a Visual Analogue Scale raging from 0=no pain to 100= maximum unbearable pain. Normal value will be absence of pain.


Other Outcome Measures:
  1. Implicit association test (IAT) [ Time Frame: Day 1 ]
    Implicit racial bias measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446456


Contacts
Contact: Research Coordinator 410-706-5975 nrscollocalab@umaryland.edu
Contact: Nathaniel Haycock, MS nhaycock@umaryland.edu

Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Luana Colloca, MD/PHD/MS University of Maryland Baltimore School of Nursing

Publications:
Responsible Party: Luana Colloca, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT03446456     History of Changes
Other Study ID Numbers: HP-00076723
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The BDI II question (#9) asks the participant to rate their feelings of suicidal thoughts or wishes. The research staff will review each participant's response after completion at each study visit to assess if the participant shows the potential for harm to self or others. Any participant who scores a 2 or 3 on that item or has a total score of 29 or more will be referred to their provider for follow-up. The investigators will call 911 for any participant who experiences a medical or psychological emergency during the experiment. Similarly, the MASQ item 61 asks about "Thought about death or suicide". In case of a positive answer, participants will be referred to their provider for follow-up.

The only other information that will be shared with the participant is incidental findings from the MRI. Participants will be referred to their primary care physician for follow up. A copy of the MRI scan on disk can be provided to the participant.

Time Frame: Duration of the Study
Access Criteria: Data will only be shared with participant to whom it pertains.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Luana Colloca, University of Maryland:
Magnetic Resonance Imaging
Healthy Volunteers

Additional relevant MeSH terms:
Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs