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 — DRUGIntranasal vasopressin will be administered shortly before the fMRI experiment.
- Saline — OTHERIntranasal saline will serve as a placebo for participants in the Saline Arm
- Observational learning — BEHAVIORALDuring 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 — OTHERAll 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: SalineUnder 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 vasopressinUnder 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
- Research Coordinator410-706-5975
- Rachel Massalee, MS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Luana Colloca | Baltimore | Maryland | 21201-1512 |
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