Healthy AdultsPhase 2POPPNCT05326776
Peripheral Oxytocin and Touch
A Phase 2 study testing Pitocin in people with Healthy Adults, run by University of California, San Diego at 1 site in United States.
Trial summary
Research shows that slow gentle skin stroking can activate special sensory nerves in the skin that elicit relaxing effects on the body and mind, similar to the effects of the hormone oxytocin. Studies also suggest that gentle stroking may even release oxytocin in the skin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Pitocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to 3 Aug 2023
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65 years old
- Fluent in English
- Healthy
Who cannot join
- Sensory or motor nerve deficit
- Acute or chronic pain
- Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
- 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
- Unstable psychiatric conditions
- Needle phobia or history of fainting
Show all 14Show fewer
- Current use of opiate medication(s)
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- Currently pregnant or pregnant within the last two years
- Currently nursing or lactating
- Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval
- Past or current history of hyponatremia or at risk for hyponatremia
- Current use of thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, selective serotonin reuptake inhibitors, monoamine oxidase inhibitora, or the recreational drug ecstasy
- Latex allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Peripheral Oxytocin on Touch Pleasantness and Pain
Research shows that slow gentle skin stroking can activate special sensory nerves in the skin that elicit relaxing effects on the body and mind, similar to the effects of the hormone oxytocin. Studies also suggest that gentle stroking may even release oxytocin in the skin. However, we do not know what oxytocin does in the skin and how it affects nerves that send pleasant touch or pain signals to the brain. The proposed study will determine how individuals perceive gentle stroking and experimental pain before and after a skin injection of oxytocin compared to a placebo injection.
- Conditions
- Healthy Adults
- Being tested
- Pitocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitocinDrug
At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
| Study group | Role | What they receive |
|---|---|---|
| Order 1 | Experimental | Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm. Receives: Drug: Pitocin |
| Order 2 | Experimental | Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm. Receives: Drug: Pitocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Pleasantness Rating of Gentle Brushing
Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a "Pleasantness/Unpleasantness" Visual Analog Scale with anchors of "Extremely unpleasant" (coded -100) to "Neutral" to "Extremely pleasant (coded 100)." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions. Higher values indicate increased pleasantness (better outcome).
Measured: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Change in Mechanical Threshold
"Mechanical threshold" task. Change in first reported percept of sharpness from application of a standard set of weighted pinprick stimuli (minimum 8mN; maximum 512 mN) will be compared between the oxytocin and placebo sessions. An increased threshold indicates reduced sensitivity to mechanical pain.
Measured: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Change in Temporal Summation of Pinprick Stimuli
Temporal summation will be tested using a standard 256 milliNewtons (mN) pinprick stimulus applied for 10 repetitions. The participant will provide pain ratings for a single pinprick and for the 10 repetitions, using a Visual Analog Scale rating scale with anchors "No pain" to "Most intense pain imaginable." This procedure will be repeated 5 times and the mean pain rating for the repeated pinprick will be divided by the mean rating of the single pinprick to obtain the standard temporal summation ratio. Change in ratio will be compared between the oxytocin and placebo sessions.
Measured: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Secondary outcomes (3)
Pressure Pain Threshold
Pressure pain threshold will be tested using a pressure algometer placed over the dorsal forearm muscles, and pressure will be increased until pain is reported. When pain is reported, the pressure level (in pounds of force) is recorded as the outcome measure.
Measured: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Heat Pain Threshold
Heat pain threshold (HPT) will be tested using a high-quality thermode. To establish HPT, the thermode will be placed on the arm at a baseline temperature of 32 Celsius and will be increased until the stimulus is reported as painful by the participant. The mean of three trials will be taken as the HPT.
Measured: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Heat Pain Ratings
Three 10s trials of the individually calibrated heat stimulus rated 70/100 will be rated using using a "Pain Intensity" Visual Analog Scale rating scale with anchors "No pain" (coded -100) to "Most intense pain imaginable (coded 100)." Higher scores indicate more intense pain (worse outcome).
Measured: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start5 Apr 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
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 Healthy AdultsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Case, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326776
- Sponsor's protocol ID
- 802467
- Acronym
- POPP
- Status last verified
- Dec 2024
- First submitted
- 4 Apr 2022
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data may be shared with other researchers per request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peripheral Oxytocin on Touch Pleasantness and Pain
- ClinicalTrials.gov ID
- NCT05326776
- Acronym / sponsor ID
- POPP / 802467
- Conditions
- Healthy Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that slow gentle skin stroking can activate special sensory nerves in the skin that elicit relaxing effects on the body and mind, similar to the effects of the hormone oxytocin. Studies also suggest that gentle stroking may even release oxytocin in the skin. However, we do not know what oxytocin does in the skin and how it affects nerves that send pleasant touch or pain signals to the brain. The proposed study will determine how individuals perceive gentle stroking and experimental pain before and after a skin injection of oxytocin compared to a placebo injection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Order 1 | Experimental | Drug: PitocinParticipants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm. |
| Order 2 | Experimental | Drug: PitocinParticipants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 65 years old
- Fluent in English
- Healthy
Key exclusion criteria (14 listed)
- Sensory or motor nerve deficit
- Acute or chronic pain
- Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
- 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
- Unstable psychiatric conditions
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 |
|---|---|---|
| PitocinAt each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance. | Drug | Order 1, Order 2 |
Primary outcome
Change in Mean Pleasantness Rating of Gentle Brushing
Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a "Pleasantness/Unpleasantness" Visual Analog Scale with anchors of "Extremely unpleasant" (coded -100) to "Neutral" to "Extremely pleasant (coded 100)." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions. Higher values indicate increased pleasantness (better outcome).
Change in Mechanical Threshold
Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
"Mechanical threshold" task. Change in first reported percept of sharpness from application of a standard set of weighted pinprick stimuli (minimum 8mN; maximum 512 mN) will be compared between the oxytocin and placebo sessions. An increased threshold indicates reduced sensitivity to mechanical pain.
Change in Temporal Summation of Pinprick Stimuli
Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Temporal summation will be tested using a standard 256 milliNewtons (mN) pinprick stimulus applied for 10 repetitions. The participant will provide pain ratings for a single pinprick and for the 10 repetitions, using a Visual Analog Scale rating scale with anchors "No pain" to "Most intense pain imaginable." This procedure will be repeated 5 times and the mean pain rating for the repeated pinprick will be divided by the mean rating of the single pinprick to obtain the standard temporal summation ratio. Change in ratio will be compared between the oxytocin and placebo sessions.
3 secondary outcomes
Pressure Pain Threshold
Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Heat Pain Threshold
Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Heat Pain Ratings
Time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data may be shared with other researchers per request.
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Active, not recruiting
Deliver-EE: Evaluating Effects of Meal Delivery
Healthy
Not yet recruiting
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
Recruiting
Nicotinamide Riboside, Vit B3 Analogue, and Brain Energy Metabolism
Healthy Adult
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pitocin in people with Healthy Adults, run by University of California, San Diego 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 3 inclusion and 14 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 31 Dec 2024. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 31 Dec 2024). 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 Mean Pleasantness Rating of Gentle Brushing (time frame: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.