NCT02393443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

January 22, 2015

Last Update Submit

August 8, 2017

Conditions

Keywords

oxytocinhealthy sampleintranasal administrationlearning

Outcome Measures

Primary Outcomes (1)

  • Changes in brain neural activity, observed by fMRI, in response to a reading comprehension task

    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.

    Between 40-90 minutes post administration

Secondary Outcomes (1)

  • Performance on a memory test of reading comprehension as measured by percentage of questions answered correctly

    Between 40-90 minutes post administration

Study Arms (2)

Intranasal oxytocin

EXPERIMENTAL

Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).

Drug: Intranasal oxytocin

Intranasal placebo

PLACEBO COMPARATOR

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.

Drug: Intranasal placebo

Interventions

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).

Also known as: Syntocinon nasal spray
Intranasal oxytocin

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.

Intranasal placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Department of Psychology

Los Angeles, California, 90095-1563, United States

Location

Related Publications (1)

  • Straccia MA, Teed AR, Katzman PL, Tan KM, Parrish MH, Irwin MR, Eisenberger NI, Lieberman MD, Tabak BA. Null results of oxytocin and vasopressin administration on mentalizing in a large fMRI sample: evidence from a randomized controlled trial. Psychol Med. 2023 Apr;53(6):2285-2295. doi: 10.1017/S0033291721004104. Epub 2021 Oct 15.

Study Officials

  • Matthew D Lieberman, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Matthew D. Lieberman, PhD

Study Record Dates

First Submitted

January 22, 2015

First Posted

March 19, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations