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Study · Non-randomized trial · 2015

10 results

Phase 1 safety assessment of intrathecal oxytocin.

Eisenach JC, Tong C, Curry R

Anesthesiology1 Feb 2015Cited by 19 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In healthy volunteers, one subject at the highest intrathecal oxytocin dose had transient hypotension.

    In plain wordsIn healthy volunteers, one person given the highest dose of oxytocin into the spinal fluid had a short drop in blood pressure.

    Peptide
    Oxytocin
    Outcome
    Not applicableTransient hypotension (adverse event)
    Study

    n: not reported in source

    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    One subject receiving the highest dose experienced transient hypotension
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  2. 02HumanNon-randomized trialSafety outcome

    In healthy volunteers, one subject at the highest intrathecal oxytocin dose had transient bradycardia.

    In plain wordsIn healthy volunteers, one person given the highest dose of oxytocin into the spinal fluid had a short slowing of the heart rate.

    Peptide
    Oxytocin
    Outcome
    Not applicableTransient bradycardia (adverse event)
    Study

    n: not reported in source

    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    One subject receiving the highest dose experienced transient hypotension and bradycardia
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  3. 03HumanNon-randomized trialSafety outcome

    In healthy volunteers, one subject at the highest intrathecal oxytocin dose had subjective numbness in a lumbo-sacral distribution.

    In plain wordsIn healthy volunteers, one person given the highest dose of oxytocin into the spinal fluid felt numbness in the lower back area.

    Peptide
    Oxytocin
    Outcome
    Not applicableSubjective numbness (adverse event)
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    One subject receiving the highest dose experienced transient hypotension and bradycardia as well as subjective numbness in a lumbo-sacral distribution.
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  4. 04HumanNon-randomized trialSafety outcome

    In healthy volunteers, no other subject had subjective or objective neurologic symptoms after intrathecal oxytocin.

    In plain wordsIn healthy volunteers, no other person had nerve-related symptoms after oxytocin was given into the spinal fluid.

    Peptide
    Oxytocin
    Outcome
    No significant changeOther neurologic symptoms
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    5, 15, 50 or 150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    No other subject experienced subjective or objective neurologic symptoms.
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy volunteers, blood pressure rose by less than 15% from 1 to 4 h after intrathecal oxytocin, with no dose dependency.

    In plain wordsIn healthy volunteers, blood pressure rose a little, by less than 15%, in the hours after oxytocin into the spinal fluid.

    Peptide
    Oxytocin
    Outcome
    IncreaseBlood pressure change after injection
    Study

    n: not reported in source

    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    5, 15, 50 or 150 μg · intrathecalAs given in this study (human).

    Measurements

    Blood pressure increase
    < 15%
    1 to 4 h after injection

    Source sentences

    Summary
    Overall, blood pressure and heart rate increased 1 to 4 h after injection by less than 15% with no dose dependency.
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy volunteers, heart rate rose by less than 15% from 1 to 4 h after intrathecal oxytocin, with no dose dependency.

    In plain wordsIn healthy volunteers, heart rate rose a little, by less than 15%, in the hours after oxytocin into the spinal fluid.

    Peptide
    Oxytocin
    Outcome
    IncreaseHeart rate change after injection
    Study

    n: not reported in source

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    5, 15, 50 or 150 μg · intrathecalAs given in this study (human).

    Measurements

    Heart rate increase
    < 15%
    1 to 4 h after injection

    Source sentences

    Summary
    Overall, blood pressure and heart rate increased 1 to 4 h after injection by less than 15% with no dose dependency.
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  7. 07HumanNon-randomized trialSafety outcome

    In healthy volunteers, intrathecal oxytocin had no effect on serum sodium measured 24 h later.

    In plain wordsIn healthy volunteers, oxytocin into the spinal fluid did not change blood sodium.

    Peptide
    Oxytocin
    Outcome
    No significant changeSerum sodium at 24 h
    Study

    n: not reported in source

    Outcome group
    Adverse events · Kidney and urinary
    Studied dose
    5, 15, 50 or 150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    There was no effect on serum sodium, and cerebrospinal fluid oxytocin increased in a dose-dependent manner after injection.
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  8. 08HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, cerebrospinal fluid oxytocin increased in a dose-dependent manner after intrathecal injection.

    In plain wordsIn healthy volunteers, oxytocin levels in the spinal fluid rose with the dose given.

    Peptide
    Oxytocin
    Outcome
    IncreaseCerebrospinal fluid oxytocin
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 15, 50 or 150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    cerebrospinal fluid oxytocin increased in a dose-dependent manner after injection.
    1 context sentence
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  9. 09HumanNon-randomized trialEfficacy outcome

    In healthy volunteers, pain scores to noxious heat stimuli in arm and leg were unaffected by intrathecal oxytocin.

    In plain wordsIn healthy volunteers, oxytocin into the spinal fluid did not change pain scores for heat stimuli.

    Peptide
    Oxytocin
    Outcome
    No significant changePain scores to noxious heat stimuli
    Study

    n: not reported in source

    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    5, 15, 50 or 150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    Pain scores to noxious heat stimuli were unaffected by oxytocin
    2 context sentences
    Summary · context
    Cerebrospinal fluid was obtained 60 min after injection, and responses to noxious heat stimuli in arm and leg as well as temporal summation to repeated application of a von Frey filament were obtained.
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.
  10. 10HumanNon-randomized trialEfficacy outcome

    In healthy volunteers, the temporal summation protocol showed no summation before or after intrathecal oxytocin.

    In plain wordsIn healthy volunteers, the repeated-touch pain test showed no build-up of pain before or after oxytocin into the spinal fluid.

    Peptide
    Oxytocin
    Outcome
    No significant changeTemporal summation to repeated von Frey filament
    Study

    n: not reported in source

    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    5, 15, 50 or 150 μg · intrathecalAs given in this study (human).

    Source sentences

    Summary
    the temporal summation protocol failed to show summation before or after drug treatment.
    2 context sentences
    Summary · context
    Cerebrospinal fluid was obtained 60 min after injection, and responses to noxious heat stimuli in arm and leg as well as temporal summation to repeated application of a von Frey filament were obtained.
    Summary · context
    After institutional review board and Food and Drug Administration approval, healthy adult volunteers received 5, 15, 50, or 150 μg intrathecal oxytocin in a dose-escalating manner in cohorts of five subjects.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 01:30 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:49 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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