Apply the PD Model of Peripheral Oxytocin Action to a Multimodal Stimulus

NCT04433741 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB00066443
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain). In this study healthy volunteers are recruited. Each study participant will have an IV catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion of oxytocin or placebo (inactive solution). The investigators will perform some tests to evaluate how oxytocin changes perceptions on the skin. The investigators will study a painful perception by placing a probe on the skin and heating it to 116.6 degrees Fahrenheit for 30 seconds and a vibratory stimulus will be applied to the forearm with vibration begun at a 1 kHz frequency and decreased at a rate of 25 Hz/sec until the subject first perceives the vibration. Each study participant will score any pain that is experienced on a 0 to 10 scale and will report when the vibration is detected. Each participant will receive oxytocin and placebo in a random order and will be blinded to group they are receiving.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (4)

• Heat pain with vibration

  Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  Baseline before infusion

• Heat pain with vibration

  Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  5 minutes post infusion initiation

• Heat pain with vibration

  Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  15 minutes post infusion initiation

• Heat pain with vibration

  Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  30 minutes post infusion initiation

Secondary Outcomes (4)

• Heat pain without vibration

  Baseline

• Heat pain without vibration

  5 minutes post infusion initiation

• Heat pain without vibration

  15 minutes post infusion initiation

• Heat pain without vibration

  30 minutes post infusion initiation

Study Arms (2)

Oxytocin First, then Placebo

OTHER

Oxytocin administered intravenously for the first half of the study and then will receive intravenous placebo for the second half.

Drug: Oxytocin; Drug: Placebo

Placebo, Then Oxytocin

OTHER

Placebo administered intravenously for the first half of the study and then will receive intravenous oxytocin for the second half.

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

Oxytocin administered intravenously

Also known as: Pitocin

Oxytocin First, then Placebo; Placebo, Then Oxytocin

Placebo DRUG

Placebo administered intravenously

Oxytocin First, then Placebo; Placebo, Then Oxytocin

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 or 2.
• For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication.
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

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

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, outcomes assessor and investigator will be blinded to the randomization order. Research pharmacist will prepare each infusion.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross over model: each participant will be randomized to receive oxytocin and placebo in a random order

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)