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Hormone Therapy
Intranasal Oxytocin for Alcoholism
Phase 2
Recruiting
Led By Raye Litten, PHD
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
oral contraceptives
Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing whether intranasal oxytocin can help people with Alcohol Use Disorder drink less.
Who is the study for?
Adults over 21 with moderate to severe Alcohol Use Disorder seeking treatment can join this trial. They must be sober at consent, stable on any anxiety or depression meds for 2 months, and not planning to move or have legal issues that could affect participation. Women of childbearing potential must agree to use birth control.Check my eligibility
What is being tested?
The study tests if intranasal oxytocin can reduce heavy drinking days in people with Alcohol Use Disorder over a period of 10 weeks. It also looks at oxytocin's impact on psychological state, cravings, smoking habits, study retention, safety, and nasal application site tolerance.See study design
What are the potential side effects?
Specific side effects are not listed but may include reactions related to the nasal administration site and possible systemic effects due to oxytocin's action in the body. Safety and tolerability will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
I am currently taking oral contraceptives.
Select...
I am not using oxytocin and agree not to use it during the study.
Select...
I am 21 years old or older.
Select...
I am 21 years old or older.
Select...
I am not using oxytocin and agree not to use it during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weekly Percentage of Heavy Drinking Days
Secondary outcome measures
Abstinence from cigarette smoking among smokers
Cigarettes smoked per week among smokers
Experiences in Close Relationships-Relationship Structures Questionnaire (ECR-RS) scores (attachment-related anxiety)
+14 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Intranasal OxytocinActive Control1 Intervention
Oxytocin, 35 IU per dose, intranasally twice-daily. One dose is defined as intranasal spray of 100 ΞΌL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 ΞΌL. The total daily dose of oxytocin will be 70 IU/mL.
Group II: Instrasal PlaceboPlacebo Group1 Intervention
Identically matched placebo administered intranasally twice-daily. One dose is defined as intranasal spray of 100 ΞΌL per each nostril x 5 sprays in alternating nostrils with a 30 second wait between sprays for a total dose volume of 500 ΞΌL.
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Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
799 Previous Clinical Trials
1,362,411 Total Patients Enrolled
422 Trials studying Alcoholism
985,108 Patients Enrolled for Alcoholism
Raye Litten, PHDPrincipal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with alcohol use disorder in the past year.You are able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.You are currently seeking treatment for reducing your alcohol intake.I've been on a steady dose of my depression or anxiety medication for the last 2 months.I agree to use effective birth control if I can become pregnant.I am not using oxytocin and agree not to use it during the study.I can travel to the study site without major issues by Week 14.I agree to use effective birth control if I can become pregnant.I can attend all study visits and participate in phone calls without major conflicts.I've been on a steady dose of my depression or anxiety medication for the last 2 months.I can travel to the study site without major issues by Week 14.I can use nasal sprays and will follow the treatment plan.I am 21 years old or older.I am 21 years old or older.I am not using oxytocin and agree not to use it during the study.I am currently taking oral contraceptives.I can use nasal sprays and will follow the treatment plan.I agree to attend all visits, participate in phone calls, and have no conflicts that would prevent my participation.
Research Study Groups:
This trial has the following groups:- Group 1: Instrasal Placebo
- Group 2: Intranasal Oxytocin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration (FDA) given authorization to Intranasal Oxytocin?
"Our evaluation at Power gave Intranasal Oxytocin a score of 2 - corresponding to Phase 2 trials wherein there is validating data for safety but none that confirms efficacy."
Answered by AI
Are there opportunities for enrolment in this trial available at present?
"Evidently, this clinical trial is searching for participants as the details on clinicaltrials.gov were last revised on August 2nd 2022 following its initial posting on May 5th 2022."
Answered by AI
What is the cap for enrollment in this medical experiment?
"Affirmative. Documentation available on clinicaltrials.gov attests that this experiment, which was unveiled on May 5th 2022, is presently recruiting volunteers. An estimated 100 people are needed to join the trial from five different medical facilities."
Answered by AI
To what extent has Intranasal Oxytocin been tested in previous research trials?
"Hadassah University Medical Organization was the first to conduct research on intranasal oxytocin back in 2011. Since then, 311 studies have been finished and an additional 53 are currently underway; most of these experiments take place at medical centres based in Baltimore, Maryland."
Answered by AI
To which ailments is intranasal oxytocin commonly prescribed?
"Intranasal Oxytocin is traditionally used to address hemorrhage and can also be deployed for other medical purposes, including labor induction, uterine contraction augmentation, and labour reinforcement."
Answered by AI
Are there numerous locations performing this experiment in North America?
"Currently, 5 different clinical trial sites are welcoming patients. These locations include Baltimore, Charlottesville and Boston as well as other nearby towns. To reduce travel needs during this study's duration, it is advised that patients pick the nearest site to them for enrolment."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
University of California
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Because I need help. And I want to change. Because I need help. And I want to change. And I want to get healthy for me and my kids.
PatientReceived no prior treatments
Using Alcohol and nicotine use are harming my relationship with my partner, I would like to find a way to stop or severly reduce alcohol and nicotine use.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Will I know dates for screening in advance? Is this study payed?
PatientReceived 2+ prior treatments
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