Healthy ControlsPhase 2NCT02652195
Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II
A Phase 2 study testing Oxytocin in people with Healthy Controls and Alcohol Use Disorder, run by University of Utah at 1 site in United States.
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 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls, Alcohol Use Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jun 2024
- Phase
- Phase 2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years of age at the time of screening
Who cannot join
- 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)
- Psychiatric Illness Criteria:
- Controls: No current or past history of psychiatric illness, including substance use disorder (except nicotine)
- AUD: No history of, or current, psychotic disorder, antisocial personality disorder, or bipolar disorder, or concurrent post-traumatic stress disorder. Must meet DSM-5 criteria for current moderate-to-severe AUD, abstinent from alcohol for 2-8 weeks prior to study enrollment, express a desire to achieve abstinence or to greatly reduce alcohol consumption
- Illicit Drug Use
- Control: Any reported current (within the last 2 months) use of any category of illicit drugs
Show all 15Show fewer
- Patients: Dependence (moderate to severe) to any other substance within the last 2 months other than alcohol or nicotine
- Any current or past history of any serious medical or neurological illness
- Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction, hyponatremia, traumatic brain injury, atrophic rhinitis, recurrent nose bleeds, and cranial-surgical procedures (hypophysectomy).
- Abnormal MRI (except if due to technical factors)
- Female subjects who are pregnant, trying to become pregnant, or nursing
- Known allergies to oxytocin or to preservatives in the nasal spray
- Participants reporting use of an intranasal medication in the past two weeks
- Participants taking medications including any current treatment with antipsychotics, antidepressants, mood stabilizers, psychostimulants and psychostimulant appetite suppressants, or past treatment with isoniazid, glucocorticoids, centrally active antihypertensive drugs (e.g., clonidine, reserpine), or sedative hypnotic medications (e.g. benzodiazepines, barbiturates, within 1 week prior to study enrollment). Treatment within six months with any of the following: hormone use (i.e. testosterone, DHEA), opioid drugs.
- Unable to comply with study procedures or protocols
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Mental Health Institute - University of Utah HealthCare
Salt Lake City, Utah, 84108
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, the investigators will characterize oxytocin's effects on the neural processing of salient stimuli. The investigators 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.
Ongoing clinical trials are examining the use of intranasal oxytocin for the treatment of multiple psychiatric disorders including substance dependence, depression, and schizophrenia; disorders which reward system dysfunction appears to play a significant role. As such, it is important that we obtain a better understanding of the neurobiological effects this drug may have on reward circuitry functioning. To this end, in this study, we will examine healthy control participants and participants diagnosed with Alcohol Use Disorder (AUD).
- Conditions
- Healthy Controls, Alcohol Use Disorder
- Being tested
- Placebo, Oxytocin
- Keywords
- Neural correlates, oxytocin administration
- Medical subject headings
- Alcoholism
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 prior to scanning session.
OxytocinDrug
Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff, delivered prior to scanning session.
| 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: Control group
Measured: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group
Measured: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls
Measured: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2022
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Mickey, University of Utah
- Investigators
- Tiffany Love, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652195
- Sponsor's protocol ID
- IRB_00086964
- Status last verified
- Sep 2023
- First submitted
- 7 Jan 2016
- Last updated
- 26 Sep 2023
- 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 Sep 2023. 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. Part II
- ClinicalTrials.gov ID
- NCT02652195
- Acronym / sponsor ID
- IRB_00086964
- Conditions
- Healthy Controls, Alcohol Use Disorder
- Keywords
- Neural correlates, oxytocin administration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 11 Jan 2016 (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 proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.
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, the investigators will characterize oxytocin's effects on the neural processing of salient stimuli. The investigators 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.
Ongoing clinical trials are examining the use of intranasal oxytocin for the treatment of multiple psychiatric disorders including substance dependence, depression, and schizophrenia; disorders which reward system dysfunction appears to play a significant role. As such, it is important that we obtain a better understanding of the neurobiological effects this drug may have on reward circuitry functioning. To this end, in this study, we will examine healthy control participants and participants diagnosed with Alcohol Use Disorder (AUD).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, 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
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-45 years of age at the time of screening
Key exclusion criteria (15 listed)
- 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)
- Psychiatric Illness Criteria:
- Illicit Drug Use
- Any current or past history of any serious medical or neurological illness
- Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction, hyponatremia, traumatic brain injury, atrophic rhinitis, recurrent nose bleeds, and cranial-surgical procedures (hypophysectomy).
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 prior to scanning session. | Drug | Placebo |
| OxytocinOxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff, delivered prior to scanning session. | Drug | Oxytocin |
Primary outcome
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: Control group
Time frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group
Time frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls
Time frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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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.
Tiffany Love, PhD principal investigator
University of Utah
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 Healthy Controls and Alcohol Use Disorder, run by University of Utah 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 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. 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?
Results are not available in the source record.
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: Control group (time frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)). 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 26 Sep 2023.