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

NCT02652195 | Unknown Phase 2 FDA Drug

• 1 other identifier: IRB_00086964
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Controls; Alcohol Use Disorder

Keywords

Neural correlates; oxytocin administration

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Interventions

Placebo DRUG

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

Placebo

Oxytocin DRUG

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

Oxytocin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age at the time of screening

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Mental Health Institute - University of Utah HealthCare

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tiffany Love, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 11, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

US (1)