Focus of Study: Neural Correlates of Oxytocin AdministrationPhase 2NCT01722071

Deciphering the Role of Oxytocin in Motivation: an fMRI Study

A Phase 2 study testing Oxytocin in people with Focus of Study: Neural Correlates of Oxytocin Administration, run by Tiffany Love 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

The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation. Read more about this study

Who is it for?: Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Focus of Study: Neural Correlates of Oxytocin Administration
What is being tested?: Oxytocin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Oct 2012to Oct 2015
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 20 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male
20-35 years of age at the time of screening
Right-handedness
Non-smoking
No current or past history of neurological or psychiatric illness, including substance abuse or dependence
No acute medical illness
Written informed consent obtained from subject

Who cannot join

Female
Left-handedness or ambidextrous
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Known allergies to oxytocin or to preservatives in the nasal spray
Participants who exhibit nasal obstruction or upper-respiratory tract infection at the time of scanning or report the use of intranasally administered medications for up to two weeks prior to screening
Participants unable to tolerate the scanning procedures or would be unfit for scanning purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of the scan)

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Any current or past history of medical, neurological, or psychiatric illness or family history of psychiatric or neurologic disease in first-degree relatives
Neurological illness, abnormal MRI (except if due to technical factors)
Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction.
Participants currently taking medications including any treatment, current or past with antipsychotics, mood stabilizers, isoniazid, glucocorticoids, psychostimulants and psychostimulant appetite suppressants, or centrally active antihypertensive drugs (e.g., clonidine, reserpine).
Treatment within six months with any of the following: hormone use (testosterone, DHEA), antidepressants, opioid drugs.
Treatment within one month with sedative hypnotic medications (benzodiazepines, barbiturates), or over the counter sleeping aids
Current or past history of substance abuse or dependence
Any reported lifetime use of any category of illicit drugs
Positive urine drug screen

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.

Read the detailed description

Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of prosocial effects in humans including enhancing trust and generosity, improving positive communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks. With this study, we will characterize oxytocin's effects on the neural processing of salient stimuli. We will utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI), to assess brain activity while participants perform tests designed to engage neural circuits associated with the processing of social and non-social stimuli.

Conditions: Focus of Study: Neural Correlates of Oxytocin Administration
Being tested: Placebo, Oxytocin
Keywords: Oxytocin, Functional Magnetic Resonance Imaging, Social, Motivation

What participants receive

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

PlaceboDrug
Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
OxytocinDrug
Also called Syntocinon®
Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.

Study groups in NCT01722071
Study group	Role	What they receive
Placebo	Placebo comparator	Each participant will be studied using fMRI following self-administration of placebo. Receives: Drug: Placebo
Oxytocin	Experimental	Each participant will be studied using fMRI following self-administration of oxytocin. Receives: Drug: Oxytocin

What is being measured

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

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.
Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.
Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).
Measured: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).

Timeline

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

Oct 2012Oct 2015

First posted6 Nov 2012 (estimated)
Study startOct 2012
Primary completionSep 2013
Study completionOct 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Focus of Study: Neural Correlates of Oxytocin AdministrationStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01722071
Sponsor's protocol ID: UL1RR024986
Status last verified: Dec 2015
First submitted: 29 Oct 2012
Last updated: 29 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mickey BJ, Heffernan J, Heisel C, Pecina M, Hsu DT, Zubieta JK, Love TM. Oxytocin modulates hemodynamic responses to monetary incentives in humans. Psychopharmacology (Berl). 2016 Dec;233(23-24):3905-3919. doi: 10.1007/s00213-016-4423-6. Epub 2016 Sep 10.
PubMed 27614896

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Deciphering the Role of Oxytocin in Motivation: an fMRI Study
ClinicalTrials.gov ID: NCT01722071
Acronym / sponsor ID: UL1RR024986
Conditions: Focus of Study: Neural Correlates of Oxytocin Administration
Keywords: Oxytocin, Functional Magnetic Resonance Imaging, Social, Motivation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Tiffany LoveUniversity, hospital or other
Collaborators: University of Michigan
Study start: Oct 2012
Primary completion: Sep 2013 (actual)
Study completion: Oct 2015 (actual)
First posted: 6 Nov 2012 (estimated)
Results: Posted 29 Jun 2015

Clinical summary

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

The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboEach participant will be studied using fMRI following self-administration of placebo.
Oxytocin	Experimental	Drug: OxytocinEach participant will be studied using fMRI following self-administration of oxytocin.

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male
20-35 years of age at the time of screening
Right-handedness
Non-smoking
No current or past history of neurological or psychiatric illness, including substance abuse or dependence

Key exclusion criteria (15 listed)

Female
Left-handedness or ambidextrous
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Known allergies to oxytocin or to preservatives in the nasal spray
Participants who exhibit nasal obstruction or upper-respiratory tract infection at the time of scanning or report the use of intranasally administered medications for up to two weeks prior to screening

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
PlaceboPlacebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.	Drug	Placebo
OxytocinAlso: Syntocinon®Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.	Drug	Oxytocin

Primary outcome

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
Time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions. Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis. Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).

Results and safety

Results posted to the registry on 29 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Then Oxytocin	10	9
Oxytocin Then Placebo	10	10

Primary outcome: Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.

Time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).. Mean (Standard Error). Unit: BOLD signal change (beta values)

Measure	Placebo Then Oxytocin n = 8	Oxytocin Then Placebo n = 10
Placebo	0.7944 (0.3252)	0.5790 (0.2515)
Oxytocin	0.6119 (0.2040)	0.6688 (0.3642)

Placebo Then Oxytocin vs Oxytocin Then Placebo: p = 0.890, t-test, 2 sided
Placebo Then Oxytocin: p = 0.422, t-test, 2 sided
Oxytocin Then Placebo: p = 0.814, t-test, 2 sided

Population analysed: Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.

Adverse events

Time frame: Adverse event data was collected on each scanning day and 24 hours later (i.e. assessed at 4 different time points for each participant).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Then Oxytocin	0 of 10 (0%)	0 of 10 (0%)	Not reported
Oxytocin Then Placebo	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27614896Mickey BJ, Heffernan J, Heisel C, Pecina M, Hsu DT, Zubieta JK, Love TM. Oxytocin modulates hemodynamic responses to monetary incentives in humans. Psychopharmacology (Berl). 2016 Dec;233(23-24):3905-3919. doi: 10.1007/s00213-016-4423-6. Epub 2016 Sep 10.

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.

Tiffany M Love, PhD principal investigator

University of Michigan

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 Oxytocin in people with Focus of Study: Neural Correlates of Oxytocin Administration, run by Tiffany Love 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 7 inclusion and 15 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 29 Jan 2016. 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 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 29 Jun 2015). 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?

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. (time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).). 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 NCT01722071, which also lists 1 linked publication.

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 29 Jan 2016.