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Peptide Hormone

Oxytocin for Alcoholism and Healthy Controls

Phase 2

Waitlist Available

Led By Tiffany Love, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-45 years of age at the time of screening

Be between 18 and 65 years old

Must not have

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).

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial will look at how oxytocin affects the brain's response to social and non-social activities.

Who is the study for?

This study is for people aged 18-45 who can handle an MRI scan without issues like metal implants or claustrophobia. It's not for those with serious medical conditions, pregnant/nursing women, or anyone allergic to oxytocin. Participants shouldn't be on certain medications including antipsychotics and antidepressants.

What is being tested?

The trial tests how a nasal spray of oxytocin versus a placebo affects brain activity related to motivation in both social and non-social contexts, using fMRI scans to observe changes.

What are the potential side effects?

Oxytocin may cause side effects such as irritation at the site of administration, headaches, nausea, changes in heart rate or blood pressure, emotional changes, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have untreated illnesses or a history of serious liver, kidney, brain issues, nose conditions, or major head surgeries.

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I am not currently on certain mental health meds or have taken specific drugs in the past 6 months.

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I am not pregnant, trying to conceive, or breastfeeding.

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I have a history of serious medical or neurological illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765

Blood transfusion

100%

80%

60%

40%

20%

Study treatment Arm

Oral Misoprostol-Mothers

Oxytocin-Mothers

Oral Misoprostol-Fetus/Neonate

Oxytocin-Fetus/Neonate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OxytocinExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxytocin

2016

Completed Phase 4

~2340

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,140 Previous Clinical Trials

1,697,642 Total Patients Enrolled

Tiffany Love, PhD5.0373 ReviewsPrincipal Investigator - University of Utah

Intermountain Medical Center, Saint Mark's Hospital

Medical School - University of Utah, Doctor of Medicine

University of Utah, Residency in Obstetrics and Gynecology

5Patient Review

They were extremely detail-oriented and patient in answering all of my questions. I would recommend this doctor to anybody seeking a high-quality medical professional.