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Hormone Therapy

Oxytocin Nasal Spray for Alcohol and Smoking Cravings

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
18 to 55 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-7 days
Awards & highlights

Study Summary

This trial will study the effects of oxytocin compared to placebo on alcohol and cigarette cravings in smokers with an alcohol use disorder.

Who is the study for?
This trial is for non-treatment-seeking adults aged 18-55 who smoke at least 5 cigarettes a day, have an alcohol use disorder, and are in good health. Participants must be right-handed with normal vision or corrected-to-normal vision, not currently using psychoactive medications, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the effects of oxytocin nasal spray versus placebo on cravings triggered by alcohol-related cues in smokers with an alcohol use disorder. It includes fMRI scans to observe brain responses and measures changes in craving levels, consumption habits, heart rate, blood pressure, and mood.See study design
What are the potential side effects?
Oxytocin may cause side effects such as headaches, nausea, dizziness or emotional changes. Since it's administered via nasal spray, some participants might experience irritation or discomfort in their nose.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-7 days 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 craving
Brain activity
Cigarette craving
Secondary outcome measures
Ethanol

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Oxytocin nasal sprayActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,967 Total Patients Enrolled
423 Trials studying Alcoholism
985,678 Patients Enrolled for Alcoholism
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,324 Total Patients Enrolled
29 Trials studying Alcoholism
5,485 Patients Enrolled for Alcoholism

Media Library

Oxytocin nasal spray (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04071119 — Phase 1
Alcoholism Research Study Groups: Oxytocin nasal spray, Placebo
Alcoholism Clinical Trial 2023: Oxytocin nasal spray Highlights & Side Effects. Trial Name: NCT04071119 — Phase 1
Oxytocin nasal spray (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04071119 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned Oxytocin nasal spray for medicinal use?

"As this is an early Phase 1 trial, where safety and efficacy data are limited, Oxytocin nasal spray received a score of 1."

Answered by AI

Is enrolment for this research endeavor still accessible to individuals?

"Affirmative. Details on clinicaltrials.gov verify that this trial, first posted in November 2020, is actively recruiting participants. 55 individuals must be sourced from 1 medical site for the study to move forward."

Answered by AI

Are geriatric individuals eligible to partake in this experiment?

"Individuals, who are at least 18 years of age and not beyond 55, can sign up for this study."

Answered by AI

In what medical contexts is Oxytocin nasal spray regularly employed?

"Oxytocin nasal spray is often employed to help manage excessive bleeding during labour, as well as intense uterine contractions."

Answered by AI

How many volunteers are partaking in this clinical experiment?

"Confirmed. Based on the clinicaltrials.gov page, enrollment for this trial is currently open; it was initially listed on November 9th 2020 and last updated February 28th 2022. The research team seeks to recruit 55 patients at a single site."

Answered by AI

Am I eligible to partake in this experiment?

"For eligibility in this clinical trial, applicants must suffer from a diagnosis of alcohol use disorder and be between 18-55. There is capacity for up to fifty-five participants."

Answered by AI

Who else is applying?

What state do they live in?
New York
Connecticut
How old are they?
18 - 65
What site did they apply to?
Center for Alcohol and Addiction Studies
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
Recent research and studies
clinicaltrials.govStudy
Alcohol and Cigarette Craving During Oxytocin Treatment
Kimberly Goodyear 2020. "Alcohol and Cigarette Craving During Oxytocin Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04071119.
~7 spots leftby Apr 2025
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