Socioemotional AgingPhase 2/3NCT02409862
Faces: Choices Study
A Phase 2/3 study testing Oxytocin Spray in people with Socioemotional Aging, run by University of Florida at 1 site in United States.
Trial summary
The neuropeptide oxytocin (OXT), originally known for its role in inducing uterine contractions has been shown to be involved in many of the social capacities that seem to change with age, such as emotion detection and identification, enhanced social memory, empathy, and trust. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Socioemotional Aging
- What is being tested?
- Oxytocin Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 30 Aug 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-33 (for the younger adults) and 60-85 (for the older adults)
- Male
- Caucasian
- English fluency
Who cannot join
- Severe claustrophobia
- Currently on vasoconstrictors, pseudoephedrine or antidiuretic medication
- Surgery on the brain or any prior serious brain damage or disease
- Dementia or severe cognitive disorders
- History of hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone, psychogenic polydipsia, or motion disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32611-2250
About this study
The neuropeptide oxytocin (OXT), originally known for its role in inducing uterine contractions has been shown to be involved in many of the social capacities that seem to change with age, such as emotion detection and identification, enhanced social memory, empathy, and trust. Thus, age-related changes in the OXT system may underlie differences between young and older adults in socioemotional functioning. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging. The aim of this research is to examine the behavioral and neural effects of OXT on decisions of trust in social interactions, perceptions of facial trustworthiness, the ability to read faces, and levels of empathy with other people in samples of young and older adults.
Read the detailed description
Overview: This study has three parts: An initial screening visit and two study visits. All visits to be conducted at the Institute on Aging at the University of Florida.
Screening Visit - Screening: Together with the information obtained in the phone screening, the main purpose of the screening visit is to find out if the participants are eligible to participate in the study.
- One of the investigators trained researchers will ask the participant questions about their health condition, and recent activities.
- The participant will be given instructions and assistance in the collection of saliva to determine the baseline level of cortisol in their body.
- A trained researcher will then ask the participant questions about their personality and experiences in close relationships.
- The participant will then be asked to provide the second saliva sample to find out how the activity of their genes may impact their cognition and behavior during the tasks they engage in as part of the study.
- The researcher will then conduct two cognitive tests (Digit Substitution Task, Verbal Learning Test).
- This will be followed by a blood test to screen for medical conditions that may indicate that the participant should not participate in the study, such as certain blood levels elevated out of normal range. The blood test will also be used to determine the level of oxytocin, testosterone, and estrogen in the participant's body that occur normally.
- The participant will then have a brief consultation with a licensed physician, to go over their medical review. This will not be a clinical doctor visit for routine medical care, but a visit to confirm the participant's healthy medical status to participate in the research study.
Study Visits -
- A researcher will ask the participant to answer a short questionnaire comprising questions about activities and events during the last 24 hours.
- A researcher will ask for the participant to respond to a short questionnaire related to their current mood.
- The participant will be asked to provide a first saliva sample to determine the baseline level of oxytocin in their body on the day of testing.
- The participant will be asked to self-administer either the oxytocin or a placebo, into their nose by using a nasal spray bottle. Oxytocin is a hormone that naturally occurs in the body and has been shown to be relevant for many behaviors, especially in social situations. The participant will be assigned by chance, much like the flip of a coin, to receive either the oxytocin or the placebo during the first study visit. The participant will then receive the other during the second study visit respectively.
- The participant will then be asked to participate in an electroencephalography (EEG) recording session, that is recording of electrical activity along their scalp. An EEG cap, selected for the participant's head size, will be placed on their head. During this part of the study, the participant will sit in a comfortable chair while working on the Choice Task on the computer screen or resting.
- While recording EEG, the participant's eye movements will be monitored with an eye tracker. The eye-tracking camera will be placed so that it can capture the participant's eyes and after a brief calibration procedure will track the participant's eye movements while working on the task or resting.
- The Choice Task will involve making decisions that involve the participant as well as a fellow player. Before the task starts, the participant will receive detailed information and have a chance to ask any questions that they may have about the task or about the EEG and eye tracking procedures. They will also have the chance to work on some practice trials.
- Next, the participant will be asked to provide a second saliva sample to determine the level of oxytocin in their body after they have received the oxytocin or placebo and some time has passed.
- After the Choice Task, the participant will complete a few more questionnaires, including questions about feelings and thoughts about themselves and others, and questions about how they completed the Choice Task and whether they experienced any drug side effects or any discomfort during the EEG or eye tracking.
- The second study visit will take place about a week after the first study visit, and will be identical in procedure.
- Both visits will be followed up by a brief phone call from a researcher about 3 days after the study visit.
- Upon completion of the study, the participant will receive study reimbursement. A researcher will tell the participant about the general goals of the study and answer any questions that they may have.
- Conditions
- Socioemotional Aging
- Being tested
- Oxytocin Spray, Placebo Spray
- Keywords
- oxytocin, socioemotional functioning, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin SprayDrug
Also called synthetic oxytocin
This group will receive the single dose of 24 IU oxytocin, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.
Placebo SprayDrug
Also called saline spray
This group will receive the single dose of 24 IU placebo, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin Spray | Experimental | This group will receive the single dose of 24 IU oxytocin, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording. Receives: Drug: Oxytocin Spray |
| Placebo spray | Placebo comparator | This group will receive the single dose of 24 IU saline, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording. Receives: Drug: Placebo Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in choices task between baseline and at week 2
Interactive computer task that determines willingness to give money to a fellow player.
Measured: Change between baseline and at week 2
Secondary outcomes (6)
The change in General Trust Measure Questionnaire between baseline and at week 2
Participants will work on the 11-item General Trust Measure (General Trust Measure; Rothstein, 2011), which assesses participants' level of trust on a scale ranging from 1 = strongly disagree to 7 = strongly agree. With a total overall score of 77 being the best possible score, and 11 is the worst overall score.
Measured: Change between baseline and at week 2
The change in Empathy Quotient Questionnaire between baseline and at week 2
Participants will fill out a 22-item version of the Empathy Quotient (EQ-Short; Wakabayashi et al., 2006), on a scale ranging from 1 = strongly disagree to 5 = strongly agree. With a total overall score of 110 being the best possible score, and 22 is the worst overall score. This measure assesses empathy, as the drive to identify emotions and thoughts in others and to respond to these with an appropriate emotion.
Measured: Change between baseline and at week 2
The change in Trait Meta-Mood Scale Questionnaire between baseline and at week 2
Participants will respond to seven items from two subscales (Attention to feelings; Clarity of feelings) of the Trait Meta-Mood Scale (TMMS; Salovey, Mayer, Goldman, Turvey, \& Palfai, 1995), as a measure of emotional attention and clarity, using a scale ranging from 1 = strongly disagree to 5 = strongly agree. With a total overall score of 35 being the best possible score, and 7 is the worst overall score.
Measured: Change between baseline and at week 2
The change in Inclusion of Community in the Self Scale Questionnaire between baseline and at week 2
Participants will respond to a modified version of the Inclusion of Community in the Self Scale (#14-ICS; Mashek, Cannaday, \& Tangney, 2007). This measure assesses the connectedness an individual feels to other people. Participants will be presented pictures of two circles with different degrees of overlap (representing different extents of connectedness) and will be told that one circle represents themselves and the other circle represents people of a particular age group (young, older). Participants will be asked to mark the picture that best describes their connectedness with the age group specified. This will be repeated for each of the two age groups, counterbalanced across participants. Participants will select a maximum of one picture per age group.
Measured: Change between baseline and at week 2
Gift basket task
Participants are given the choice to give their fellow players either a candy or fruit basket.
Measured: Week 2
Donation task
Participants are given the option to donate their reimbursement to a charity.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start1 Jan 2019 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Why it stopped: Technical issues preventing recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socioemotional AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie C Ebner, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409862
- Sponsor's protocol ID
- IRB201600718 -A
- Other IDs
- 39-2013 SubStudy
- Status last verified
- Nov 2018
- First submitted
- 12 Mar 2015
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faces: Choices Study
- ClinicalTrials.gov ID
- NCT02409862
- Acronym / sponsor ID
- IRB201600718 -A
- Conditions
- Socioemotional Aging
- Keywords
- oxytocin, socioemotional functioning, aging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical issues preventing recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The neuropeptide oxytocin (OXT), originally known for its role in inducing uterine contractions has been shown to be involved in many of the social capacities that seem to change with age, such as emotion detection and identification, enhanced social memory, empathy, and trust. Thus, age-related changes in the OXT system may underlie differences between young and older adults in socioemotional functioning. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging. The aim of this research is to examine the behavioral and neural effects of OXT on decisions of trust in social interactions, perceptions of facial trustworthiness, the ability to read faces, and levels of empathy with other people in samples of young and older adults.
Detailed description
Overview: This study has three parts: An initial screening visit and two study visits. All visits to be conducted at the Institute on Aging at the University of Florida.
Screening Visit - Screening: Together with the information obtained in the phone screening, the main purpose of the screening visit is to find out if the participants are eligible to participate in the study.
- One of the investigators trained researchers will ask the participant questions about their health condition, and recent activities.
- The participant will be given instructions and assistance in the collection of saliva to determine the baseline level of cortisol in their body.
- A trained researcher will then ask the participant questions about their personality and experiences in close relationships.
- The participant will then be asked to provide the second saliva sample to find out how the activity of their genes may impact their cognition and behavior during the tasks they engage in as part of the study.
- The researcher will then conduct two cognitive tests (Digit Substitution Task, Verbal Learning Test).
- This will be followed by a blood test to screen for medical conditions that may indicate that the participant should not participate in the study, such as certain blood levels elevated out of normal range. The blood test will also be used to determine the level of oxytocin, testosterone, and estrogen in the participant's body that occur normally.
- The participant will then have a brief consultation with a licensed physician, to go over their medical review. This will not be a clinical doctor visit for routine medical care, but a visit to confirm the participant's healthy medical status to participate in the research study.
Study Visits -
- A researcher will ask the participant to answer a short questionnaire comprising questions about activities and events during the last 24 hours.
- A researcher will ask for the participant to respond to a short questionnaire related to their current mood.
- The participant will be asked to provide a first saliva sample to determine the baseline level of oxytocin in their body on the day of testing.
- The participant will be asked to self-administer either the oxytocin or a placebo, into their nose by using a nasal spray bottle. Oxytocin is a hormone that naturally occurs in the body and has been shown to be relevant for many behaviors, especially in social situations. The participant will be assigned by chance, much like the flip of a coin, to receive either the oxytocin or the placebo during the first study visit. The participant will then receive the other during the second study visit respectively.
- The participant will then be asked to participate in an electroencephalography (EEG) recording session, that is recording of electrical activity along their scalp. An EEG cap, selected for the participant's head size, will be placed on their head. During this part of the study, the participant will sit in a comfortable chair while working on the Choice Task on the computer screen or resting.
- While recording EEG, the participant's eye movements will be monitored with an eye tracker. The eye-tracking camera will be placed so that it can capture the participant's eyes and after a brief calibration procedure will track the participant's eye movements while working on the task or resting.
- The Choice Task will involve making decisions that involve the participant as well as a fellow player. Before the task starts, the participant will receive detailed information and have a chance to ask any questions that they may have about the task or about the EEG and eye tracking procedures. They will also have the chance to work on some practice trials.
- Next, the participant will be asked to provide a second saliva sample to determine the level of oxytocin in their body after they have received the oxytocin or placebo and some time has passed.
- After the Choice Task, the participant will complete a few more questionnaires, including questions about feelings and thoughts about themselves and others, and questions about how they completed the Choice Task and whether they experienced any drug side effects or any discomfort during the EEG or eye tracking.
- The second study visit will take place about a week after the first study visit, and will be identical in procedure.
- Both visits will be followed up by a brief phone call from a researcher about 3 days after the study visit.
- Upon completion of the study, the participant will receive study reimbursement. A researcher will tell the participant about the general goals of the study and answer any questions that they may have.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin Spray | Experimental | Drug: Oxytocin SprayThis group will receive the single dose of 24 IU oxytocin, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording. |
| Placebo spray | Placebo comparator | Drug: Placebo SprayThis group will receive the single dose of 24 IU saline, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-33 (for the younger adults) and 60-85 (for the older adults)
- Male
- Caucasian
- English fluency
Key exclusion criteria (5 listed)
- Severe claustrophobia
- Currently on vasoconstrictors, pseudoephedrine or antidiuretic medication
- Surgery on the brain or any prior serious brain damage or disease
- Dementia or severe cognitive disorders
- History of hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone, psychogenic polydipsia, or motion disorder
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 |
|---|---|---|
| Oxytocin SprayAlso: synthetic oxytocinThis group will receive the single dose of 24 IU oxytocin, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording. | Drug | Oxytocin Spray |
| Placebo SprayAlso: saline sprayThis group will receive the single dose of 24 IU placebo, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording. | Drug | Placebo spray |
Primary outcome
The change in choices task between baseline and at week 2
Time frame: Change between baseline and at week 2
Interactive computer task that determines willingness to give money to a fellow player.
6 secondary outcomes
The change in General Trust Measure Questionnaire between baseline and at week 2
Time frame: Change between baseline and at week 2
The change in Empathy Quotient Questionnaire between baseline and at week 2
Time frame: Change between baseline and at week 2
The change in Trait Meta-Mood Scale Questionnaire between baseline and at week 2
Time frame: Change between baseline and at week 2
The change in Inclusion of Community in the Self Scale Questionnaire between baseline and at week 2
Time frame: Change between baseline and at week 2
Gift basket task
Time frame: Week 2
Donation task
Time frame: Week 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
Related trials for Socioemotional Aging
Recruiting
Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging
Aging, Cognitive Change
Not yet recruiting
Connecting Socioemotional Aspects of Exercise to Improvements in Physical Health Among Older Adults
Motivation, Aging
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.
Natalie C Ebner, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxytocin Spray in people with Socioemotional Aging, run by University of Florida 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 5 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: withdrawn, as of the sponsor's last update on 26 Nov 2018. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The change in choices task between baseline and at week 2 (time frame: Change between baseline and at week 2). 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 26 Nov 2018.