NCT05823441

Brief Summary

This study recruited healthy volunteers and randomly divided them into four groups. They inhaled oxytocin or saline, and watched a pain test video with photos of acquaintances or strangers, respectively, to test whether their feelings of the same thermal pain stimulus had changed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

March 28, 2023

Last Update Submit

January 30, 2024

Conditions

OxytocinPainEmpathySocial FamiliarityAnalgesia

Outcome Measures

Primary Outcomes (1)

  • NRS score

    numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".

    Half an hour after inhaling spray

Secondary Outcomes (8)

  • EEG

    about 3 hours

  • Brief Profile Of Mood States

    about 3 hours

  • Beck Depression Inventory

    about 3 hours

  • WLEIS-C

    about 3 hours

  • STAI

    about 3 hours

  • +3 more secondary outcomes

Study Arms (4)

OS group

PLACEBO COMPARATOR

Half an hour after the volunteers inhaled 24 units of oxytocin spray, they watched the pre recorded video (attached with pictures and introductions of strangers) and underwent a pain test.

Drug: Oxytocin nasal sprayBehavioral: Stranger

PS group

PLACEBO COMPARATOR

Half an hour after the volunteers inhaled the same amount of saline spray, they watched the pre recorded video (with pictures and introductions of strangers attached) and received a pain test.

Drug: PlaceboBehavioral: Stranger

OA group

EXPERIMENTAL

Half an hour after the volunteers inhaled 24 units of oxytocin spray, they watched the pre recorded video (attached with pictures and introductions of acquaintances) and underwent a pain test.

Drug: Oxytocin nasal sprayBehavioral: Acquaintance

PA group

PLACEBO COMPARATOR

Half an hour after the volunteers received the same dose of saline, they watched the pre recorded video (attached with pictures and introductions of acquaintances) and received the pain test.

Drug: PlaceboBehavioral: Acquaintance

Interventions

Oxytocin nasal sprayDRUG

Volunteers inhale 24 units of oxytocin spray

OA groupOS group
PlaceboDRUG

Volunteers inhale 24 units of placebo spray

PA groupPS group
StrangerBEHAVIORAL

Volunteers watch a video of a pain test and attach a photo of a stranger

OS groupPS group
AcquaintanceBEHAVIORAL

Volunteers watch a video of a pain test and attach a photo of an acquaintance

OA groupPA group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • During pregnancy;
  • Have participated in any research related to pain;
  • Sleep disorders;
  • Used alcohol, caffeine, nicotine, or other psychoactive substances within 24 hours before the test;
  • Experienced intense pain requiring medical analgesia within three months prior to the trial;
  • Taking any medication, including over the counter medication;
  • Addiction to alcohol, tobacco, or drugs;
  • A history of any respiratory, circulatory, neurological, musculoskeletal, and/or mental illness;
  • Current symptoms of depression and/or anxiety. (See quantitative sensor testing for specific standards)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of anesthesiology

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 21, 2023

Study Start

June 3, 2023

Primary Completion

January 21, 2024

Study Completion

January 21, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

CN(1)