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Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II

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ClinicalTrials.gov Identifier: NCT02652195
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Tiffany Love, University of Utah

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

Condition or disease Intervention/treatment Phase
Healthy Controls Alcohol Use Disorder Drug: Placebo Drug: Oxytocin Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II
Study Start Date : November 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Placebo Comparator: Placebo
Each participant will be studied using fMRI following self-administration of placebo.
Drug: Placebo
Placebo intranasal administration, 3 puffs per nostril, delivered prior to scanning session.

Experimental: Oxytocin
Each participant will be studied using fMRI following self-administration of oxytocin.
Drug: Oxytocin
Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff, delivered prior to scanning session.




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18-45 years of age at the time of screening

    Exclusion Criteria:

  2. 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)
  3. Psychiatric Illness Criteria:

    1. Controls: No current or past history of psychiatric illness, including substance use disorder (except nicotine)
    2. 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
  4. Illicit Drug Use

    1. Control: Any reported current (within the last 2 months) use of any category of illicit drugs
    2. Patients: Dependence (moderate to severe) to any other substance within the last 2 months other than alcohol or nicotine
  5. Any current or past history of any serious medical or neurological illness
  6. 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).
  7. Abnormal MRI (except if due to technical factors)
  8. Female subjects who are pregnant, trying to become pregnant, or nursing
  9. Known allergies to oxytocin or to preservatives in the nasal spray
  10. Participants reporting use of an intranasal medication in the past two weeks
  11. 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.
  12. Unable to comply with study procedures or protocols

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652195


Contacts
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Contact: Bryan Crum 385-645-3674 bryan.crum@hsc.utah.edu

Locations
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United States, Utah
University Neuropsychiatric Institute - University of Utah HealthCare Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Bryan Crum    801-587-8972    bryan.crum@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Tiffany Love, PhD University of Utah
  Study Documents (Full-Text)

Documents provided by Tiffany Love, University of Utah:
Study Protocol  [PDF] November 6, 2019
Informed Consent Form  [PDF] November 6, 2019


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Responsible Party: Tiffany Love, Ph.D., University of Utah
ClinicalTrials.gov Identifier: NCT02652195    
Other Study ID Numbers: IRB_00086964
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Tiffany Love, University of Utah:
Neural correlates
oxytocin administration
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs