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Oxytocin for Alcoholism

Phase 2
Waitlist Available
Led By Julianne Flanagan, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.
Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments (> 26 on the Mini-Mental State Exam).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 month follow up
Awards & highlights

Study Summary

This trial is testing whether oxytocin, a hormone that has been shown to reduce substance use behaviors and improve the neurobiological foundations of addiction, can improve outcomes in Alcohol Behavioral Couples Therapy.

Who is the study for?
This trial is for couples where at least one partner has an alcohol use disorder, are intellectually capable of understanding the study (scoring over 26 on a mental state exam), and are in a stable relationship. They must not have severe psychiatric conditions or be at risk of needing hospitalization during the study.Check my eligibility
What is being tested?
The trial tests if oxytocin can enhance Alcohol Behavioral Couple Therapy outcomes by improving symptoms of alcohol use disorder, relationship functioning, and brain connectivity related to addiction. Participants will receive either oxytocin or placebo alongside their therapy sessions.See study design
What are the potential side effects?
Oxytocin may cause side effects such as emotional changes, mild headaches, nausea, or injection site reactions. However, many people tolerate it well without significant issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of my mental health medication for at least 4 weeks.
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I can understand and agree to the study's requirements.
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I have been in a committed relationship for at least 6 months.
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I can understand and agree to the study's requirements.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Days Abstinent
Drunk driving
Total Score of Relationship Functioning

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.
Group II: PlaceboPlacebo Group1 Intervention
A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,790 Total Patients Enrolled
417 Trials studying Alcoholism
983,211 Patients Enrolled for Alcoholism
Medical University of South CarolinaLead Sponsor
929 Previous Clinical Trials
7,393,623 Total Patients Enrolled
46 Trials studying Alcoholism
4,911 Patients Enrolled for Alcoholism
Julianne Flanagan, PhD5.01 ReviewsPrincipal Investigator - Medical University of South Carolina
Medical University of South Carolina

Media Library

Oxytocin Clinical Trial Eligibility Overview. Trial Name: NCT03846505 — Phase 2
Alcoholism Research Study Groups: Placebo, Oxytocin
Alcoholism Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT03846505 — Phase 2
Oxytocin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03846505 — Phase 2

Frequently Asked Questions

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

What indications typically warrant Oxytocin treatment?

"Oxytocin is a commonly employed treatment for issues like hemorrhage, labour augmentation, uterine contraction induction, and the strengthening of labor."

Answered by AI

Could individuals aged fifty and above participate in this trial?

"This experiment is open to those 18-75 years old, with 29 trials for minors and 234 focused on seniors."

Answered by AI

Is recruitment currently occurring for this clinical trial?

"Affirmative. According to information available on clinicaltrials.gov, this research study is in the midst of recruiting participants at one location with an intended sample size of 200 individuals - it was initial posted on May 16th 2019 and most recently updated December 16th 2021."

Answered by AI

Is Oxytocin sanctioned for therapeutic use by the FDA?

"Despite the lack of evidence in favor of Oxytocin's efficacy, prior clinical data suggests that it can be deemed relatively safe and so is given a score of two."

Answered by AI

What is the current enrollment tally for this research endeavor?

"Affirmative, clinicaltrials.gov lists this particular trial as open for recruitment. It was initially made available to the public on May 16th 2019 and last updated December 16th 2021. A total of 200 participants are needed at one location."

Answered by AI

What type of individuals have the greatest potential to benefit from participating in this clinical study?

"This clinical trial is looking for 200 consenting adults between 18 and 75 years old who suffer from alcohol addiction. Eligibility criteria necessitates that the participant is married, cohabiting for at least six months or in a dedicated relationship of one year duration; male or female, any race/ethnicity; experienced hazardous drinking episode within last two months; meets DSM-5 diagnostic conditions of recent (last 6 month) alcohol use disorder; can have concurrent substance abuse provided that alcoholic beverages are their primary choice of intoxicant and taking psychotropic medications with consistent dose over 4 weeks prior to study onset as fluctuating doses may compromise outcomes."

Answered by AI
~33 spots leftby Mar 2025