Chronic PainPhase 4NCT03935399

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

A Phase 4 study testing Oxytocin and Saline in people with Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: Oxytocin and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 8 Aug 2019to 30 Apr 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory

Read the detailed description

This protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test of Aβ and of Aδ fiber sensitivity in injured skin following ultraviolet B (UVB) burned skin.

For the primary goal - to examine the effects of oxytocin peripheral nerves after tissue injury - the investigators chose the controlled ultraviolet sunburn model.

The investigators propose a randomized, blinded, cross over design with treatment with oxytocin one day and placebo on another. Following baseline measures on each of the two study days, participants will receive an intramuscular injection of oxytocin (Pitocin®) in its indicated dose of 10 IU (17 μg) or an equivalent volume of saline.

In order to determine the highest frequency that Aβ nerve fibers can respond to, the investigators will use a device that produces an oscillatory / vibratory stimulus which can be used on the hand.

Pain threshold to punctate stimulation within the area of irradiation will be determined using calibrated von Frey filaments and an up-down sequential method which efficiently estimates median thresholds.

Thermal heat testing will also be performed by the surface of the skin of the forearm or leg is heated to 45°C using a computer controlled thermode for a period of 5 minutes.

Conditions: Chronic Pain
Being tested: Oxytocin, Saline
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Also called Pitocin
10 IU oxytocin (Pitocin) for intramuscular injection
SalineDrug
1.5 ml preservative free saline for intramuscular injection

Study groups in NCT03935399
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Oxytocin; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 5 minutes to 65 minutes

Secondary outcomes (3)

Change in Sustained Heat After IM Injection Non Dominant Arm
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature after IM Oxytocin or placebo injection.
Measured: From 21 minutes to 125 minutes
Change in Sustained Heat After IM Injection
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 40 degree Celsius temperature applied to the site of the UV burn after IM Oxytocin or placebo injection.
Measured: From 36 minutes to 40 minutes
Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg)
Verbal pain scores (0 to 10; 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable) to 45 degree Celsius temperature applied to the calf (lower leg) after IM Oxytocin or placebo injection.
Measured: From 21 minutes to 65 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 201930 Apr 2020

First posted2 May 2019
Study start8 Aug 2019
Primary completion15 Mar 2020
Study completion30 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Double blinded crossover treatment with oxytocin and placebo (saline)
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03935399
Sponsor's protocol ID: IRB00056660
Status last verified: Mar 2021
First submitted: 24 Apr 2019
Last updated: 5 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
ClinicalTrials.gov ID: NCT03935399
Acronym / sponsor ID: IRB00056660
Conditions: Chronic Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 8 Aug 2019 (actual)
Primary completion: 15 Mar 2020 (actual)
Study completion: 30 Apr 2020 (actual)
First posted: 2 May 2019 (actual)
Results: Posted 5 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory

Detailed description

This protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test of Aβ and of Aδ fiber sensitivity in injured skin following ultraviolet B (UVB) burned skin.

For the primary goal - to examine the effects of oxytocin peripheral nerves after tissue injury - the investigators chose the controlled ultraviolet sunburn model.

In order to determine the highest frequency that Aβ nerve fibers can respond to, the investigators will use a device that produces an oscillatory / vibratory stimulus which can be used on the hand.

Thermal heat testing will also be performed by the surface of the skin of the forearm or leg is heated to 45°C using a computer controlled thermode for a period of 5 minutes.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Double blinded crossover treatment with oxytocin and placebo (saline)

Arm	Type	Receives
Oxytocin first, then saline placebo	Other	Drug: Oxytocin, Drug: SalineIntramuscular injection of oxytocin (Pitocin®), 10 IU on the first study day and of 1 ml saline placebo on the second study day
Saline placebo first, then oxytocin	Placebo comparator	Drug: Oxytocin, Drug: SalineIntramuscular injection of 1 ml saline placebo on the second study day and of oxytocin (Pitocin®), 10 IU on the second study day

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxytocinAlso: Pitocin10 IU oxytocin (Pitocin) for intramuscular injection	Drug	Oxytocin first, then saline placebo, Saline placebo first, then oxytocin
Saline1.5 ml preservative free saline for intramuscular injection	Drug	Oxytocin first, then saline placebo, Saline placebo first, then oxytocin

Primary outcome

Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection
Time frame: From 5 minutes to 120 minutes
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.
Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection.
Time frame: From 5 minutes to 120 minutes
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.
Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection.
Time frame: From 5 minutes to 65 minutes
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.
Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection
Time frame: From 5 minutes to 65 minutes
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.

3 secondary outcomes

Change in Sustained Heat After IM Injection Non Dominant Arm
Time frame: From 21 minutes to 125 minutes
Change in Sustained Heat After IM Injection
Time frame: From 36 minutes to 40 minutes
Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg)
Time frame: From 21 minutes to 65 minutes

Results and safety

Results posted to the registry on 5 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxytocin First, Then Saline Placebo	5	5
Saline Placebo First, Then Oxytocin	5	5

Primary outcome: Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection

Time frame: From 5 minutes to 120 minutes. Mean (Standard Deviation). Unit: Hz

Measure	Oxytocin n = 5	Placebo n = 5
Value	22 (14)	21 (8)

Oxytocin vs Placebo: p = 0.83, ANOVA

Population analysed: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for vibration FREQUENCY detection threshold and the last 5 participants were tested for vibration INTENSITY detection threshold. This outcome relates to the first 5 participants only.

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

Time frame: From 5 minutes to 120 minutes. Mean (Standard Deviation). Unit: grams

Measure	Oxytocin n = 5	Placebo n = 5
Value	0.20 (0.66)	0.29 (0.55)

Oxytocin vs Placebo: p = 0.92, ANOVA

Population analysed: Please note that the protocol was amended after the first 5 participants. The first 5 participants were tested for pain THRESHOLD to mechanical stimulation and the last 5 participants were tested for degree of pain INTENSITY to a fixed mechanical stimulation. This outcome relates to the first 5 participants only.

Primary outcome: Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection.

Time frame: From 5 minutes to 65 minutes. Mean (Standard Deviation). Unit: cm^2

Measure	Oxytocin n = 5	Placebo n = 5
Value	6.4 (8.6)	8.8 (8.6)

Oxytocin vs Placebo: p = 0.79, ANOVA

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

Time frame: From 5 minutes to 65 minutes. Mean (Standard Deviation). Unit: Hz

Measure	Oxytocin n = 5	Placebo n = 5
Value	1.8 (1.4)	1.7 (3.9)

Oxytocin vs Placebo: p = 0.93, ANOVA

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxytocin	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Placebo	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James C Eisenach, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxytocin and Saline in people with Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection (time frame: From 5 minutes to 120 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03935399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.