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Oxytocin in Alcohol Use Disorder

NCT02711189 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-04-11

No results posted yet for this study

Summary

Background:

Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may affect how the body responds to alcohol. Researchers believe oxytocin may be a possible treatment for alcoholism.

Objective:

To test whether the hormone oxytocin affects the brain reward system. To see if it affects how people respond to alcohol and other rewarding things in life like food and seeing loved ones.

Eligibility:

Men ages 21-55 who have an alcohol use disorder.

Design:

Participants will have two 6-day inpatient study visits. They will have:

* Study medication or placebo given twice daily as a nasal spray.
* Height and weight measured.
* Medical history.
* Blood and urine tests.
* Breath tested for alcohol.
* Electrocardiogram.
* An alcohol administration session. In a bar-like room, where participants will consume four alcoholic drinks.
* Magnetic resonance imaging (MRI). The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil will be placed over their head. Participants will complete tasks on a computer screen.
* In another alcohol session. they will drink an alcoholic beverage then answer questions. Participants will get a tab for eight more drinks ($3.00 per drink). They may drink any of the drinks or take the money. Participants will hold and smell a glass of water and their favorite alcoholic drink.
* Heart rate and blood pressure will be monitored.
* Saliva samples will be collected
* Computer tasks and questionnaires.

About one week after the end of visit 2, participants will return to clinic for a follow-up visit. Symptoms and side effects will be evaluated.

Conditions

  • Alcoholism

Interventions

DRUG

Oxytocin

Oxytocin nasal spray given in dose 80

OTHER

Placebo

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Mary R Lee, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-08
Primary Completion
2019-02-22
Completion
2019-02-22
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711189 on ClinicalTrials.gov