Effects of Oxytocin on Reinforcement Learning

Not Applicable

• Conditions: Learning Disabilities
• Interventions: Drug: intranasal oxytocin; Drug: intranasal placebo

• Registration Number: NCT03846271
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

The main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning.

Detailed Description

A double-blind, within-subject, placebo-controlled pharmacological EEG design will be employed. A total of 35 healthy male subjects will be recruited which will receive either intranasal placebo or oxytocin (24IU) on two separate study days (order counter-balanced, washout period at least 2 weeks). 45 minutes after treatment subjects will undergo a probabilistic feedback reinforcement learning paradigm with concurrent EEG acquisition. During the paradigm subjects will learn the reward probabilities of two different visual stimuli from probabilistic feedback provided by social stimuli (positive, negative emoticon). The paradigm includes an initial acquisition phase and a subsequent test phase.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2019-01-25
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-17
• Last Update Submitted: 2019-02-17
• Study First Posted: 2019-02-19
• Last Update Posted: 2019-02-19
• Primary Completion: 2019-03-31
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Age between 18-30
• Male sex
• Right handedness

Exclusion Criteria

• History of brain injury
• Current or history of psychiatric, neurological or internist disorder
• Current or regular use of medication, psychotropic substances, including nicotine
• Contraindications for Oxytocin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxytocin then placebo	intranasal oxytocin	Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo.
Placebo then oxytocin	intranasal oxytocin	Participants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU).
Oxytocin then placebo	intranasal placebo	Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo.
Placebo then oxytocin	intranasal placebo	Participants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU).

Primary Outcome Measures

Name	Time	Method
Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase	45-105 minutes after treatment administration	Feedback Related Negativity (FRN): a negative ERP component evoked by negative feedback relative to positive feedback during the acquisition phase will be compared between the oxytocin and placebo treatment conditions.
Neural index: Event-related potential: Error Related Negativity (ERN) during the test phase	45-105 minutes after treatment administration	Error Related Negativity (ERN): a negative ERP component evoked by incorrect responses relative to correct responses during the test phase will be compared between the oxytocin and placebo treatment conditions.

Secondary Outcome Measures

Name	Time	Method
Behavioral index: Response accuracy to superior stimuli during the acquisition phase	45-105 minutes after treatment administration	Correct responses are defined as choices of the stimulus associated with higher probability positive feedback during the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Response accuracy avoiding stimuli associated with higher probability negative feedback in the test phase.	45-105 minutes after treatment administration	Correct responses are defined as avoidance choices of stimuli associated with higher probability negative feedback. Note that stimuli pairs in this measurement are all associated with negative feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Response accuracy in response to superior stimuli associated with relative higher probability positive feedback in the test phase.	45-105 minutes after treatment administration	Correct responses are defined as choices of the stimulus associated with higher probability positive feedback. Note that stimuli pairs in this measurement are all associated with positive feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Behavioral index: Response accuracy to stimuli associated with highest probability positive feedback during the test phase	45-105 minutes after treatment administration	Correct responses are defined as choices of the stimulus associated with highest probability positive feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Response accuracy avoiding stimuli associated with highest probability negative feedback in the test phase.	45-105 minutes after treatment administration	Correct responses are defined as avoidance choices of stimuli associated with highest probability negative feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.

Trial Locations

Locations (1)

University of Electronic Science and Technology of China(UESTC); 🇨🇳 Chengdu, Sichuan, China