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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02652195
• Other study ID #: IRB_00086964
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: June 2024
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Healthy Controls

Intervention

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

Locations

Country	Name	City	State
United States	Huntsman Mental Health Institute - University of Utah HealthCare	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: Control group		Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Primary	Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group		Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Primary	Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls		Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)