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Taking people in NorwayPhase 2

Tests nasal oxytocin's effect on learning in youth with autism

Compares nasal oxytocin with placebo on learning in young people with autism.

Key facts

Who runs it
Oslo University Hospital HF
Where
Oslo, NorwaySee the site
Registry title
A randomized, placebo-controlled, double-blind, 3-period cross-over study in youth with autism spectrum disorders evaluating neural plasticity and learning after a single administration of intranasal oxytocin
Status
Recruiting
Phase
Phase 2
People taking part
98 people, planned
Started
26 Jan 2026
Expected to end
31 Dec 2027
Type of study
Interventional
Record updated
23 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for young people with a confirmed diagnosis of autism spectrum disorder. Each person gets oxytocin nasal spray and placebo in turn.

Age
12 to 25 years, both included
Sex
Males and females can join.
Disease stage
Confirmed diagnosis of autism spectrum disorder (ASD).
Earlier treatment
People cannot join if they started a new medicine or formal cognitive/behavioural therapy. Therapy taken for at least 4 weeks is not counted as new.

Main reasons for not taking part

  • Full scale IQ below 70
  • Previous nasal disease, surgery, or dependence on inhaled drugs
  • Pregnancy or currently breastfeeding
  • Epilepsy or past photosensitive seizures
  • Significant liver, kidney, hormone, heart, nerve, lung, blood or metabolic disorder in the history

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Male and female participant between the ages of 12 and 25, both inclusive
  • Participants and their caregivers (if applicable) must be able to communicate with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information
  • Participants must have a confirmed diagnosis of autism spectrum disorder (ASD)

Who cannot take part

  • Previous nasal disease, surgery, and dependence on inhaled drugs
  • Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at the experimental sessions for all menstruating individuals)
  • Epilepsy and previous history of photosensitive seizures
  • Systemic illness requiring treatment within 2 weeks prior to Study Day 1
  • New concomitant medications or formal cognitive/behavioural therapies. If a participant has been taking any medications or receiving formal cognitive/behavioural therapies for at least 4 weeks, then this is not considered a new therapy
  • Participation in any (other) clinical trial with an investigational medicinal product or medical device within 1 month prior to randomization
  • Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder
  • Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate
  • Known allergic reactions or hypersensitivity/intolerance to latex
  • Full scale IQ below 70 (due to the prerequisite ability to complete self-report measures)
  • Currently breastfeeding
  • Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrolment
  • Current significant nasal congestion due to common colds

Where in Norway

  • Oslo University Hospital HFOslo, NorwayTaking people

About the trial

What the trial wants to find out

Identify effects of oxytocin delivered intranasally (8 IU and 24 IU) on neural plasticity and learning compared to placebo in youth diagnosed with ASD

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A randomized, placebo-controlled, double-blind, 3-period cross-over study in youth with autism spectrum disorders evaluating neural plasticity and learning after a single administration of intranasal oxytocin
Plain-language title
Tests nasal oxytocin's effect on learning in youth with autismGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
23 September 2026