NCT02361177

Brief Summary

The investigators are interested in the impact of intranasal oxytocin in unethical behavior.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Shorter than P25 for early_phase_1

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

February 5, 2015

Last Update Submit

June 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Unethical behavior

    To measure unethical behavior, we will calculate whether participants took more money than they actually earned on a problem-solving task.

    130 minutes

Study Arms (2)

oxytocin

EXPERIMENTAL

Intranasal 24 IU oxytocin self-administration.

Drug: Oxytocin

placebo

PLACEBO COMPARATOR

Intranasal placebo. 125 mg of 0.5% cholorobutanol to 50 ml saline, with approximately 5 pH. The solution will then be sterilized using a 0.22 micron filter.

Drug: Oxytocin

Interventions

Intranasal oxytocin is hypothesized to amplify the influence of social norms on unethical behavior.

Also known as: syntocinon
oxytocinplacebo

Eligibility Criteria

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

You may qualify if:

  • Male

You may not qualify if:

  • \_\_\_\_\_ \_\_\_\_\_BP \> 130/85, HRT \> 95 (can be included at discretion of study physician/designee)
  • \_\_\_\_\_History of seizures
  • \_\_\_\_\_Neurological Disorder
  • \_\_\_\_\_Current psychiatric disorder
  • \_\_\_\_\_Previous psychiatric disorder (can be included at discretion of PI)
  • Date last episode (if \> 1 year, include; if \<1 year, at discretion of PI)
  • \_\_\_\_\_Current use of psychoactive drugs
  • \_\_\_\_\_Previous use of psychoactive drugs (can be included at discretion of PI) \_\_\_\_\_Date last medicated\_\_\_\_\_ \_\_\_\_\_Type of medication\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
  • \_\_\_\_\_Current use of anticoagulants
  • \_\_\_\_\_Current use of corticosteroids
  • \_\_\_\_\_Previous head trauma (can be included at discretion of PI)
  • \_\_\_\_\_Alcoholism or substance abuse
  • \_\_\_\_\_Carcinoma of the breast or prostate
  • \_\_\_\_\_Renal or Hepatic diseases
  • \_\_\_\_\_Chronic lung diseases
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.

MeSH Terms

Conditions

Antisocial Personality Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Robert A Josephs, PhD

    utaustin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 11, 2015

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 13, 2016

Record last verified: 2016-06