Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin

NCT05929339 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB000976991P01NS119159-01A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about oxytocin ( a naturally occurring hormone made in the brain that transmits messages) and the effects it may have on thermal heat pain after intravenous administration. The main question it aims to define is the time course of change in pain score after a 5 minute heating of the skin administered at intervals during and following infusion of intravenous oxytocin in order to create a Pharmacokinetic and a Pharmacodynamic model for oxytocin-induced analgesia. Participants will be asked to rate thermal heat temperatures before, during and after the intravenous infusion of oxytocin.

Conditions

Acute Pain; Chronic Pain; Healthy Volunteer

Keywords

Acute pain; Chronic Pain; Oxytocin

Outcome Measures

Primary Outcomes (1)

• Verbal Pain Score at the End of 5 Minutes of Skin Heating

  Verbal pain score measured at one minute intervals during the 5 minute heating of the skin at intervals up to180 minutes after the initiation of the oxytocin infusions, then at 24 hours and 5-7 days after oxytocin infusions. The verbal pain score at the 5 minute measurement is the primary pharmacodynamic outcome for the purpose of modeling the pharmacokinetic-pharmacodynamic relationship. Note that the timing of the primary outcome differs among arms. Pain intensity report will be recorded each minute during the heating of the skin to 45 - 47 degrees Celsius . Pain will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.

  5-7 days

Study Arms (3)

Verbal Pain Score at 10 Minutes

OTHER

Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 10 minutes after starting the intervention, then every 15 minutes until 115 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion.

Drug: Oxytocin

Verbal Pain Score at 15 Minutes

OTHER

Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 15 minutes after starting the intervention, then every 15 minutes until 120 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion.

Drug: Oxytocin

Verbal Pain Score at 20 Minutes

OTHER

Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 20 minutes after starting the intervention, then every 15 minutes until 125 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Intravenous oxytocin

Also known as: Pitocin

Verbal Pain Score at 10 Minutes; Verbal Pain Score at 15 Minutes; Verbal Pain Score at 20 Minutes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
• Female subjects of child-bearing potential and those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.

You may not qualify if:

• Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
• Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
• Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
• Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
• Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
• Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI's, MAOI, or the recreational drug ecstasy.
• Subjects with a known latex allergy.
• Subjects with a pain score rating of 1 or less during the initial training session to a 5 minute heating of 45°C- 47 °Celsius to the lower calf.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Analgesic effects from an acute, experimental pain stimulus may not mirror the presence, magnitude and duration of analgesia in clinical settings in the treatment of acute or chronic pain. Additionally, contributions if any, of expectations of efficacy (placebo effect) to pain report were not assessed in this study.

Results Point of Contact

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

jimeisenach@gmail.com

336716-4182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will receive two 30-minute infusions of oxytocin, 10 IU. The second infusion will be given 30 minutes after the completion of the first infusion. The first 8 subjects report pain at the end of 5 minutes of skin heating at intervals beginning 15 minutes after starting the first infusion. The remaining subjects will be randomized to report pain at the end of 5 minutes of skin heating at intervals beginning at either 10 or 20 minutes after starting the first infusion.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: August 17, 2023
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available upon publication or upon posting results in ClinicalTrials.gov, whichever comes first, with no expiration.
• Access Criteria: These data are freely shared to all and will be posted at the URL below

Locations

US (1)