Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

Dose Response of Intravenous Oxytocin on Sustained Heat Pain
Pain intensity was reported by the subject at the end of the 5 minute heating of the skin to 45 - 47 degrees C, using a verbal pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature was determined for each individual according to pain rating during screening visit. Pain scores obtained at 15, 30, and 45 minutes after the end of each 10 minute infusion were averaged for each individual and analyzed as th
45 min after the end of each study drug infusion

Study Arms (2)

First infusion day low dose oxytocin, Second infusion day high dose oxytocin

EXPERIMENTAL

On the first oxytocin study day, participants will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms. On the second study day they will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms.

Drug: Low dose oxytocinDrug: High dose oxytocin

First infusion day high dose oxytocin, Second infusion day low dose oxytocin

EXPERIMENTAL

On the first oxytocin study day, participants will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms. On the second study day they will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms.

Drug: Low dose oxytocin

Interventions

Low dose oxytocinDrug

10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms

Also known as: Pitocin

First infusion day high dose oxytocin, Second infusion day low dose oxytocinFirst infusion day low dose oxytocin, Second infusion day high dose oxytocin

High dose oxytocinDrug

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.
Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3.

Sponsors & Collaborators

Wake Forest University Health Sciences
Otherlead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

The original study design called for equal recruitment of subjects across three age ranges: young (18-39-year-old) middle (40 - 59-year-old) and older (60 - 75-year-old) with separate randomization in each group. The protocol was subsequently amended to remove this requirement.

Results Point of Contact

Title: Professor James C. Eisenach, MD
Organization: Wake Forest University School of Medicine

Study Officials

James C Eisenach, MD
Wake Forest University Health Sciences
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 5, 2022

Study Start

Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

First infusion day low dose oxytocin, Second infusion day high dose oxytocin

First infusion day high dose oxytocin, Second infusion day low dose oxytocin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

First infusion day low dose oxytocin, Second infusion day high dose oxytocin

First infusion day high dose oxytocin, Second infusion day low dose oxytocin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations