Effects of Oxytocin on Reinforcement Learning

The Effects of Intranasal Oxytocin on Reward Sensitivity and Performance Monitoring During Reinforcement Learning: an ERP Study

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

Study Overview

• Status: Unknown
• Conditions: Learning Disabilities
• Intervention / Treatment: Drug: intranasal oxytocin; Drug: intranasal placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhuang Qian, MD; Phone Number: 13086663679; Email: zq19910362@126.com
• Study Contact Backup: Name: Benjamin Becker, PhD; Phone Number: 86-28-61830988; Email: ben_becker@gmx.de

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611731
      • Recruiting
      • University of Electronic Science and Technology of China(UESTC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin then placebo; Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo.	Drug: intranasal oxytocin; 24 IU of oxytocin nasal spray will be applied to each subject.; Drug: intranasal placebo; an identical amount of placebo nasal spray will be applied to each subject.
Experimental: Placebo then oxytocin; Participants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU).	Drug: intranasal oxytocin; 24 IU of oxytocin nasal spray will be applied to each subject.; Drug: intranasal placebo; an identical amount of placebo nasal spray will be applied to each subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase	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.	45-105 minutes after treatment administration
Neural index: Event-related potential: Error Related Negativity (ERN) during the test phase	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.	45-105 minutes after treatment administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral index: Response accuracy to superior stimuli during the acquisition phase	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.	45-105 minutes after treatment administration
Behavioral index: Response accuracy to stimuli associated with highest probability positive feedback during the test phase	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.	45-105 minutes after treatment administration
Response accuracy avoiding stimuli associated with highest probability negative feedback in the test phase.	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.	45-105 minutes after treatment administration
Response accuracy in response to superior stimuli associated with relative higher probability positive feedback in the test phase.	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.	45-105 minutes after treatment administration
Response accuracy avoiding stimuli associated with higher probability negative feedback in the test phase.	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.	45-105 minutes after treatment administration

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China
• Investigators: Principal Investigator: Keith Kendrick, PhD, University of Electronic Science and Technology of China(UESTC)

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Anticipated): March 31, 2019
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: February 17, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 17, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Oxytocin; performance monitoring; reinforcement learning
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Learning Disabilities; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: UESTC-neuSCAN-61

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No