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Hormone Therapy

Intranasal Oxytocin for Opioid Addiction

Phase 1
Waitlist Available
Research Sponsored by MacDonald, Kai, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult men 18 years or older
Negative salivary drug screen, save for opiates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 minutes
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial will test whether oxytocin can help people with opiate dependence by improving their emotional processing and stress responses.

Who is the study for?
This trial is for adult men aged 18 or older with opiate dependence who can use a nasal spray, have been abstinent from non-prescribed opiates for at least two weeks, and are clinically stable. They must not have any other active substance dependence (except nicotine) or severe mental illnesses.
What is being tested?
The study tests intranasal oxytocin's effects on emotional processes and stress responses in patients with opioid addiction. The hypothesis suggests that oxytocin could improve brain-based functions related to emotion and stress in these individuals.
What are the potential side effects?
While the side effects of intranasal oxytocin aren't detailed here, common ones may include irritation at the application site, headache, changes in heart rate or blood pressure, nausea, fatigue, and emotional changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 18 or older.
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My drug test is clean except for prescribed pain medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cold Pressor Task

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: oxytocinExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved

Find a Location

Who is running the clinical trial?

MacDonald, Kai, M.D.Lead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02052258 — Phase 1
Opioid Addiction Research Study Groups: oxytocin
Opioid Addiction Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT02052258 — Phase 1
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02052258 — Phase 1
~27 spots leftby Nov 2025
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