Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin

University Hospital Bonn (UKB)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxytocin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03011970

OXT_KINO

Details and patient eligibility

About

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.

Full description

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

Enrollment: 116 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

116 participants in 6 patient groups, including a placebo group

Oxytocin; 24IU, 15min

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Oxytocin; 24IU, 45min

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Oxytocin; 24IU, 75min

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Oxytocin; 12IU, 45min

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Oxytocin; 48IU, 45min

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin

Placebo

Placebo Comparator group

Description:

Placebo nasal spray.

Treatment:

Drug: Placebo