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

NCT ID: NCT02652195

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2024-06-30

Brief Summary

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).

Conditions

Healthy Controls; Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Each participant will be studied using fMRI following self-administration of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo intranasal administration, 3 puffs per nostril, delivered prior to scanning session.

Oxytocin

Each participant will be studied using fMRI following self-administration of oxytocin.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff, delivered prior to scanning session.

Interventions

Placebo

Placebo intranasal administration, 3 puffs per nostril, delivered prior to scanning session.

Intervention Type: DRUG

Oxytocin

Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff, delivered prior to scanning session.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Brian Mickey

MD, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiffany Love, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Huntsman Mental Health Institute - University of Utah HealthCare

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB_00086964

Identifier Type: -

Identifier Source: org_study_id