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Hormone Therapy

Oxytocin for Opioid Use Disorder (OSCO Trial)

Phase 1
Waitlist Available
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights

OSCO Trial Summary

This trial is testing whether a medication can help reduce stress-induced craving in people with opioid use disorder.

Who is the study for?
This trial is for adults aged 18-65 with opioid use disorder who are in good health and have been on a stable dose of buprenorphine/naloxone for at least three months. Participants must not be using other substances (except marijuana, nicotine, caffeine), have no recent suicide attempts or significant electrolyte issues, and women must not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests intranasal oxytocin (40 IU) given twice daily over a week to see if it can reduce stress-induced cravings in people with opioid addiction. The goal is to understand how neuroendocrine pathways influence these cravings and potentially develop new treatments.See study design
What are the potential side effects?
While the side effects of intranasal oxytocin are generally mild, they may include nasal irritation, headache, changes in heart rate or blood pressure, emotional changes like increased trust or empathy, and possible nausea.

OSCO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and one day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid Craving
Secondary outcome measures
Safety and tolerability of oxytocin and yohimbine in OUD individuals receiving buprenorphine/naloxone: anxiety
Safety and tolerability of oxytocin and yohimbine in OUD individuals receiving buprenorphine/naloxone: heart rate (HR)
Safety and tolerability of oxytocin and yohimbine in OUD individuals receiving buprenorphine/naloxone: opiate withdrawal syndrome
+2 more
Other outcome measures
Stress-related response in OUD individuals receiving buprenorphine/naloxone: salivary cortisol

OSCO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: oxytocinExperimental Treatment1 Intervention
The oxytocin will be formulated at 5mg/0.1mL (5mg/spray) and dispensed as 10-mL nasal spray, twice a day (2 sprays per nostril) for 7 days (total daily dose: 40 international units, IU).
Group II: matching placeboPlacebo Group1 Intervention
The oxytocin-matched placebo will be formulated at 5mg/0.1mL (5mg/spray) and dispensed as 10-mL nasal spray, twice a day (2 sprays per nostril) for 7 days (total daily dose: 40 international units, IU).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intranasal oxytocin, 40 IU, twice a day for 7 days
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
563,061 Total Patients Enrolled

Media Library

Intranasal Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04051619 — Phase 1
Opioid Use Disorder Research Study Groups: matching placebo, oxytocin
Opioid Use Disorder Clinical Trial 2023: Intranasal Oxytocin Highlights & Side Effects. Trial Name: NCT04051619 — Phase 1
Intranasal Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04051619 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research restricted to any particular age group?

"For prospective patients to be considered for this clinical trial, they must fall between the age ranges of 18 and 70. Participants younger than 18 are eligible for 98 different studies while those over 65 may join 430 related research initiatives."

Answered by AI

Does the FDA sanction a twice-daily, 40 IU intranasal oxytocin dosage for one week?

"Intranasal oxytocin, 40 IU twice daily for a period of 7 days, has limited evidence supporting efficacy and safety; thus it was given the rating 1 on our scale."

Answered by AI

What criteria must a participant fulfill to join this research program?

"This clinical trial aims to enroll 50 adult individuals between 18 and 70 who are suffering from opioid abuse. To qualify for this study, participants should meet the following criteria: exhibiting DSM-5 symptoms of Opiate Use Disorder (OUD), have been on a consistent dose of buprenorphine/naloxone for three months or more, show COWS scores at 0 during screening and laboratory checkups, be male or female in good health based off medical history and bloodwork results, display an understanding of English at 8th grade level literacy standards, take their medications as prescribed by the trial's procedures and sign informed consent forms."

Answered by AI

Is recruitment still available for this clinical trial?

"Affirmative, clinicaltrials.gov records show that this medical trial is still open for enrollment. The study was initially posted on the 6th of January 2020 and has seen its most recent update on November 1st 2022 with a goal to enlist 50 patients from one site."

Answered by AI

What is the overall intake capacity for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this study is presently enrolling patients with the trial beginning on June 1st 2020 and having been last updated November 1st 2022. 50 participants are being sought from one location."

Answered by AI

What medical ailment does the continual administration of intranasal oxytocin, 40 IU, twice a day for 7 days usually address?

"Intranasal oxytocin is typically administered as 40 IU twice a day for seven days to stop bleeding. It also has clinical applications in managing uterine contractions, facilitating childbirth and augmenting labour progression."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Oxytocin, Stress, Craving, Opioid Use Disorder
Carolina Haass-Koffler 2020. "Oxytocin, Stress, Craving, Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04051619.
~4 spots leftby Apr 2025
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