Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala response vary as a function of treatment dose and dose-test latency.

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Detailed Description

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The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala vary as a function of dose and latency. In particular, the investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48 international units, IU) and three different dose-test latencies of IN-OXT administration (task starting at 15, 45 and 75min after administration) on established neural and behavioural correlates of emotion processing. As effects of OXT are particularly promising in autism, the investigators further want to investigate how autistic-like traits influence the OXT effects in exploratory post-hoc analyses

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin; 24IU, 15min

Intranasal administration, 24 international units (IU) oxytocin. Imaging starting 15min after nasal spray administration.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin; 24IU, 45min

Intranasal administration, 24 IU oxytocin. Imaging starting 45min after nasal spray administration.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin; 24IU, 75min

Intranasal administration, 24 IU oxytocin. Imaging starting 75min after nasal spray administration.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin; 12IU, 45min

Intranasal administration, 12 IU oxytocin. Imaging starting 45min after nasal spray administration

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin; 48IU, 45min

Intranasal administration, 48 IU oxytocin. Imaging starting 45min after nasal spray administration

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Placebo

Placebo nasal spray.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Oxytocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers
* Right-handed

Exclusion Criteria

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
* MRI contraindication (e.g. metal in body, claustrophobia)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes