Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin

NCT03935399 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00056660
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular (IM) injection (into the muscle) will have on an area of skin that has been exposed to ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn feeling. Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection

  Vibration frequency detection threshold in the burned area after IM Oxytocin or placebo injection will be obtained by the subject placing the forearm area that was exposed to the UV burn on the oscillatory device and informing the investigators when the first perception of vibration is felt. A recording of the frequency (1 kilo Hertz to 1 Hertz) will be documented.

  From 5 minutes to 120 minutes

• Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection.

  Verbal pain punctate stimulus detection threshold (the point where pain is first perceived) in the burned area after IM Oxytocin or Placebo injection will be obtained by using von Frey filaments (small filaments that are similar to a paint brush bristle). The skin will be touched with the filaments and the participant will state when pain is perceived and the size of the filament will be documented.

  From 5 minutes to 120 minutes

• Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection.

  Hypersensitivity in the burned area after IM Oxytocin or placebo injection will be obtained by using a von Frey filament (small filament that is similar to a paint brush bristle). The skin will be touched with the filament and the participant will state when sensitivity is perceived and the area marked and measured in centimeters squared.

  From 5 minutes to 65 minutes

• Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection

  Vibration frequency detection of a fixed frequency (256 Hertz) in the burned area after IM Oxytocin or placebo injection will be obtained. The subject will place the wrist area that was exposed to the UV burn on the oscillatory device, the fixed vibratory frequency will begin and will be increased in intensity and the subject will inform the investigators when the first perception of vibration is felt. A recording of the intensity level will be documented in Hertz.

  From 5 minutes to 65 minutes

Secondary Outcomes (3)

• Change in Sustained Heat After IM Injection Non Dominant Arm

  From 21 minutes to 125 minutes

• Change in Sustained Heat After IM Injection

  From 36 minutes to 40 minutes

• Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg)

  From 21 minutes to 65 minutes

Study Arms (2)

Oxytocin first, then saline placebo

OTHER

Intramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day

Drug: Oxytocin; Drug: Saline

Saline placebo first, then oxytocin

PLACEBO COMPARATOR

Intramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day

Drug: Oxytocin; Drug: Saline

Interventions

Oxytocin DRUG

10 IU oxytocin (Pitocin) for intramuscular injection

Also known as: Pitocin

Oxytocin first, then saline placebo; Saline placebo first, then oxytocin

Saline DRUG

1.5 ml preservative free saline for intramuscular injection

Oxytocin first, then saline placebo; Saline placebo first, then oxytocin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female \> 18 and \< 60 years of age,
• Body Mass Index (BMI) \<40
• Generally in good health as determined by the Principal Investigator based on prior medical history
• Normal blood pressure and resting heart rate without medication

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
• 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.
• 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; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest Health Sciences

eisenach@wakehealth.edu

3367164182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Investigator and outcomes assessor will be blinded. Research Pharmacist will prepare the study medication administration and hold the randomization.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded crossover treatment with oxytocin and placebo (saline)

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 2, 2019
• Study Start: August 8, 2019
• Primary Completion: March 15, 2020
• Study Completion: April 30, 2020
• Last Updated: April 5, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)