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Oxytocin and Learning for Teaching

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ClinicalTrials.gov Identifier: NCT02393443
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Matthew Lieberman, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE January 22, 2015
First Posted Date  ICMJE March 19, 2015
Last Update Posted Date August 10, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2015)
Changes in brain neural activity, observed by fMRI, in response to a reading comprehension task [ Time Frame: Between 40-90 minutes post administration ]
Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the tutor/memorizer and oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during reading comprehension compared with the grammar control passage. First level analyses will compare the response during the reading comprehension passages relative to the grammar control passages. Second level group analyses will compare the first level contrasts between the tutor vs. memorizer groups as well as the oxytocin vs. placebo groups. In regression analyses we will enter each participant's comprehension test score in the tutor and then memorizer condition as a regressor in a whole-brain and ROI analysis to determine which brain regions were more active during the encoding of the reading comprehension passage compared to the grammar control passage.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02393443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2015)
Performance on a memory test of reading comprehension as measured by percentage of questions answered correctly [ Time Frame: Between 40-90 minutes post administration ]
Accuracy will be calculated for each participant by dividing the number of correct responses by the total number of questions. We will then conduct a between-subjects 2x2 ANOVA on the accuracy scores for the four groups of interest (i.e., oxytocin-tutor, oxytocin-memorizer, placebo-tutor, placebo-memorizer). A significance level of p<.05 will be used to determine whether there are significant differences between the groups. We will examine whether there is a main effect of either factor (oxytocin vs. placebo, tutor vs. memorize) as well as an interaction between the factors of interest.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxytocin and Learning for Teaching
Official Title  ICMJE The Effects of Oxytocin on Learning With Social Versus Nonsocial Motivation
Brief Summary

One well-established cognitive theory propose a divide between social and non-social (i.e., cognitive) systems. However, recent work suggests that traditionally social systems can be utilized to enhance cognitive performance. In this study the investigators aim to explore this cooperation between oft-competing systems by instructing participants to learn information because they will be subsequently tested (the nonsocial learning-for-testing condition), or because they will be teaching the information to someone else (the prosocial learning-for-teaching condition). This latter condition relies upon the mentalizing system, which is used to contemplate another person's mental state, rather than traditional memory systems. This implies that the mnemonic powers of the mentalizing system can be leveraged in the learning of a broad array of non-social topics. Furthermore, there is also an emerging literature on the role of oxytocin, a neuropeptide naturally produced in the hypothalamus, in memory that parallels the social/nonsocial split. Oxytocin may benefit the learning-for-teaching group both in terms of enhancing initial social motivation and efficient use of the mentalizing system and then also in terms of memory consolidation for this information learning under socially-motivated conditions.

The investigators expect to replicate the basic learning-for-teaching effect such that those in the teaching condition will remember more than those in the testing conditions. They also expect an interaction between oxytocin administration and learning condition such that oxytocin administration should enhance learning for socially-motivated learning exclusively.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Social Psychology
Intervention  ICMJE
  • Drug: Intranasal oxytocin
    Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
    Other Name: Syntocinon nasal spray
  • Drug: Intranasal placebo
    Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
Study Arms  ICMJE
  • Experimental: Intranasal oxytocin
    Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
    Intervention: Drug: Intranasal oxytocin
  • Placebo Comparator: Intranasal placebo
    2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter. Participants will self-administer 5 puffs per nostril.
    Intervention: Drug: Intranasal placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2017)
161
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2015)
140
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-30 years of age
  • Healthy (see below)
  • Fluent in English
  • Right-handed

Exclusion Criteria:

  • Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women
  • Symptoms of runny nose due to allergies/cold or other reason
  • Current restricted fluid intake for any reason
  • Heart disease
  • Hypertension
  • History of myocardial infarction
  • History of cardiac arrhythmia
  • Kidney or liver disease
  • Vascular disease
  • Epilepsy
  • Migraine
  • Asthma
  • Nephritis
  • Diabetes and other endocrine diseases
  • Frequent or unexplained fainting
  • History of stroke
  • Aneurysm or brain hemorrhage
  • Active psychiatric diagnosis
  • Current psychopharmacologic treatment
  • Drug or alcohol abuse
  • Medical or neurological illness
  • Regular use of medication (e.g., vasoconstrictive medications)
  • Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs
  • Smoking more than 15 cigarettes a day
  • Consumption of any alcoholic beverages in the past 24 hours will be excluded
  • Elevated blood pressure (>135/90)
  • Low blood pressure (<90/55)
  • Body temperature >100.1 F
  • Left-handed
  • Claustrophobia
  • Presence of metal in their body
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02393443
Other Study ID Numbers  ICMJE 11-003565-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Lieberman, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew D Lieberman, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP