Social ActivityEarly Phase 1NCT00914953
Oxytocin and Social Behavior Over the Lifespan
A Early Phase 1 study testing oxytocin (Pitocin) in people with Social Activity, run by Claremont Graduate University at 1 site in United States.
Trial summary
This study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Activity
- What is being tested?
- oxytocin (Pitocin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2011
- Phase
- Early Phase 1
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residentially housed
- English fluency
Who cannot join
- non ambulatory
- severe psychiatric problems presently or in the recent past
- severe medical problems (e.g., cancer, diabetes, advanced heart disease)
- irregular heart beat
- treatment using psychoactive medications (other than antiepileptics, mood stabilizers, or Ambien)
- inability to adequately communicate with the research team
- treatment with an experimental drug
- excessive fatigue suggesting hypothyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
Linda Valley Villa
Loma Linda, California, 92354-3135
About this study
Official title: Oxytocin and Social Behavior Over the Lifespan: Interventional Study
This study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults.
Read the detailed description
Using a double-blind and placebo controlled design, this study seeks to determine if a short course of exogenous oxytocin (OT) will induce changes in social activities in residentially housed older adults (OAs) during a 10-day treatment period, and after it ends. Because OT is associated with peri-reproductive behaviors, OT release in OAs is expected to be attenuated relative to younger adults. If OT release is low in OAs as we hypothesize, augmenting OT may increase their desire for social interactions, increase the frequency of participation in social activities and augment the number of and quality of social ties, thereby providing protection against disease, early death, cognitive decline, and depression. Research in rodents suggests that social interactions themselves may change chronic OT levels (Carter \& Keverne, 2002; Carter \& Altemus, 1997), in a positive feedback loop. In order to demonstrate OT as the causal mechanism, we propose to infuse oxytocin and then track the desire for, quantity of, and quality of social activities.
- Conditions
- Social Activity
- Being tested
- oxytocin (Pitocin)
- Keywords
- social isolation, cooperative behavior, depression, loneliness, happiness, empathy
- Medical subject headings
- Social Isolation, Cooperative Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin (Pitocin)Drug
40 IU OT intranasally (IN) once-daily for 10 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | Not described Receives: Drug: oxytocin (Pitocin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
confirm increased social activities in treatment condition compared to control condition via self-report.
Measured: 30 days
Secondary outcomes (1)
Evidence of greater psychological health for treatment condition as compared to control condition.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social ActivityStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claremont Graduate University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul J. Zak, Claremont Graduate University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914953
- Sponsor's protocol ID
- CNS-R21AG029871
- Other IDs
- NIH Grant 1R21AG029871-01A2
- Status last verified
- Feb 2012
- First submitted
- 4 Jun 2009
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin and Social Behavior Over the Lifespan: Interventional Study
- ClinicalTrials.gov ID
- NCT00914953
- Acronym / sponsor ID
- CNS-R21AG029871
- Conditions
- Social Activity
- Keywords
- social isolation, cooperative behavior, depression, loneliness, happiness, empathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Claremont Graduate UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Jun 2009 (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.
This study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults.
Detailed description
Using a double-blind and placebo controlled design, this study seeks to determine if a short course of exogenous oxytocin (OT) will induce changes in social activities in residentially housed older adults (OAs) during a 10-day treatment period, and after it ends. Because OT is associated with peri-reproductive behaviors, OT release in OAs is expected to be attenuated relative to younger adults. If OT release is low in OAs as we hypothesize, augmenting OT may increase their desire for social interactions, increase the frequency of participation in social activities and augment the number of and quality of social ties, thereby providing protection against disease, early death, cognitive decline, and depression. Research in rodents suggests that social interactions themselves may change chronic OT levels (Carter \& Keverne, 2002; Carter \& Altemus, 1997), in a positive feedback loop. In order to demonstrate OT as the causal mechanism, we propose to infuse oxytocin and then track the desire for, quantity of, and quality of social activities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: oxytocin (Pitocin) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- residentially housed
- English fluency
Key exclusion criteria (8 listed)
- non ambulatory
- severe psychiatric problems presently or in the recent past
- severe medical problems (e.g., cancer, diabetes, advanced heart disease)
- irregular heart beat
- treatment using psychoactive medications (other than antiepileptics, mood stabilizers, or Ambien)
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 (Pitocin)40 IU OT intranasally (IN) once-daily for 10 consecutive days | Drug | oxytocin |
Primary outcome
confirm increased social activities in treatment condition compared to control condition via self-report.
Time frame: 30 days
1 secondary outcome
Evidence of greater psychological health for treatment condition as compared to control condition.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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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.
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 Early Phase 1 study testing oxytocin (Pitocin) in people with Social Activity, run by Claremont Graduate University 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 2 inclusion and 8 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 2 Mar 2012. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
confirm increased social activities in treatment condition compared to control condition via self-report. (time frame: 30 days). 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 2 Mar 2012.