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

Primary Purpose

Healthy Controls, Alcohol Use Disorder

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

Oxytocin

About this trial

This is an interventional basic science trial for Healthy Controls focused on measuring Neural correlates, oxytocin administration

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18-45 years of age at the time of screening
Exclusion Criteria:
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:
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
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
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

Sites / Locations

Huntsman Mental Health Institute - University of Utah HealthCare

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Oxytocin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: Control group

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls

Secondary Outcome Measures

Full Information

NCT ID

NCT02652195

First Posted

January 7, 2016

Last Updated

September 24, 2023

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT02652195

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2016 (Actual)

Primary Completion Date

June 2022 (Actual)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Controls, Alcohol Use Disorder

Keywords

Neural correlates, oxytocin administration

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Oxytocin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-45 years of age at the time of screening Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tiffany Love, PhD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huntsman Mental Health Institute - University of Utah HealthCare

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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