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Hormone Therapy

Intranasal Oxytocin for Alcoholism

Phase 2
Recruiting
Led By Martin H Plawecki, MD, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heavy alcohol drinkers.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo
Awards & highlights

Study Summary

This trial will test if oxytocin can help people with alcoholism by reducing tolerance and cravings.

Eligible Conditions
  • Alcoholism

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You drink a lot of alcohol regularly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol purchase task
Alcohol self-administration
Stop Signal Response task
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Progressive work for alcoholExperimental Treatment2 Interventions
Progressive work alcohol exposure, 2 sessions (intranasal oxytocin or placebo), double blind
Group II: ClampExperimental Treatment2 Interventions
Clamped alcohol exposure, repeated tests of subjective and cognitive effects of alcohol, 2 sessions (intranasal oxytocin or placebo), double blind
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved
Intranasal placebo
2018
Completed Phase 4
~980

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
976 Previous Clinical Trials
983,365 Total Patients Enrolled
9 Trials studying Alcoholism
1,474 Patients Enrolled for Alcoholism
Martin H Plawecki, MD, PhDPrincipal InvestigatorPsychiatry, Indiana University School of Medicine
2 Previous Clinical Trials
376 Total Patients Enrolled
2 Trials studying Alcoholism
376 Patients Enrolled for Alcoholism

Media Library

Intranasal oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05312008 — Phase 2
Alcoholism Research Study Groups: Clamp, Progressive work for alcohol
Alcoholism Clinical Trial 2023: Intranasal oxytocin Highlights & Side Effects. Trial Name: NCT05312008 — Phase 2
Intranasal oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05312008 — Phase 2

Frequently Asked Questions

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

What possible dangers are there in using oxytocin through the nose?

"Intranasal oxytocin received a safety score of 2 because, while there is some evidence backing its safety, none of the trials have been designed to test for efficacy."

Answered by AI

Are there any available spots for people who want to participate in this research?

"That is accurate. The listing on clinicaltrials.gov says that the trial is currently looking for 12 patients from 1 site. The listing was first posted on January 16th, 2022 and was last updated on March 28th, 2022."

Answered by AI

Could you please give an estimate of how many people are participating in this clinical trial?

"That is correct, the listing on clinicaltrials.gov does show that this study is looking for volunteers. This trial was first posted on 16th January 2022 and updated as recently as 28th March of the same year. They are currently only searching for 12 people to take part at a single location."

Answered by AI

Could I possibly qualify to take part in this research?

"The eligibility requirements for this study are that potential participants must drink alcohol and be between 21-60 years old. So far, 12 people have met these qualifications."

Answered by AI

Is this study only for people over the age of 85?

"Individuals between the ages of 21 and 60 who meet the other specified requirements can apply to participate in this clinical trial. There are 34 similar trials for people under 18 and another 254 for seniors above 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Mar 2025