Oxytocin in Alcohol Use Disorder

Alcoholism Clinical Trial

Official title: Oxytocin in Alcohol Use Disorder: A Novel and Translational Approach

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Objective:

There is compelling evidence to support that the neuropharmacology of oxytocin (OT) warrants further investigation as a potential therapeutic agent for addiction. To that end, the link between OT and dopaminergic pathways, with respect to motivated behaviors such as drug and social reward, is important to establish as a mechanism. Although preliminary clinical findings suggest a role of OT to treat withdrawal in alcoholic individuals, there is no direct human evidence on the effects of OT administration on dopamine release. Additionally, there is no direct human evidence on the effects of OT on the subjective response to alcohol. There have been no studies investigating the differential effect, if any, of OT, on the neurobehavioral response to various rewarding stimuli including alcohol, food and social reward. We propose, therefore, to investigate whether intranasal administration of OT is able to significantly reduce subjective response to alcohol, alcohol cue-induced craving and self-administration, as well as to examine the neural response to social, alcohol and food stimuli.

Study Population:

32 (24 completers) males with Alcohol Use Disorder (AUD) as defined by DSM-5 and non-treatment seekers for AUD.

Design:

A within-subject, double-blind placebo-controlled study investigating the effect of intranasal OT on the response to alcohol challenge, cue reactivity and alcohol self-administration, and the neural response to rewarding stimuli. Outcome measures: a) effect of OT on subjective response to cumulative alcohol challenge, cue reactivity and alcohol self-administration; b) neurobehavioral response to social, alcohol and food stimuli.

Outcome measures:

A) effect of OT on subjective response to cumulative alcohol challenge, cue reactivity and alcohol self-administration; B) neurobehavioral response to social, alcohol and food stimuli. ;

Related Conditions & MeSH terms

• Alcoholism

• NCT number: NCT02711189
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 8, 2016
• Completion date: February 22, 2019