Frontlight ResearchEarly access
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
- Trial code
- 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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData 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