Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
220
Countries
1
Sites
1
Alcohol Use Disorder (AUD)
Does oxytocin (compared to placebo) for individuals with high alcohol use increase prosocial behavior?
Key facts
- Sponsor
- Karolinska Institutet
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Trial duration
- completed 23 Apr 2025
- Decision date (initial)
- 2023-05-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Karolinska Institutet
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Does oxytocin (compared to placebo) for individuals with high alcohol use increase prosocial behavior?
Secondary objectives 1
- Does oxytocin (compared to placebo) for individuals with high alcohol use increase emotion recognition and reduce alcohol craving?
Conditions and MedDRA coding
Alcohol Use Disorder (AUD)
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-501809-13-00 | Experimental Study on Alcohol Use and Behavior in Young Adults | Karolinska Institutet |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 18-24 years of age
- Male
- Give informed consent and comply with study procedure
- High alcohol use individuals: Fulfils criteria for at least moderate AUD the past 12 months according to MINI Neuropsychiatric Interview
- High alcohol use individuals: Fulfils at least 8 points on the Alcohol Use Disorder Identification Test
Exclusion criteria 5
- Fulfils criteria for any substance use disorder (except AUD for High Alcohol-group, and mild cannabis- and nicotine use disorder for both groups).
- History of severe psychiatric disorder (e.g. severe depression, bipolar, antisocial personality disorder) or neuropsychiatric disorder of ADHD, autism or Tourette’s.
- Using intranasal medicine that could not be stopped 48 hours prior to each visit
- Allergy or intolerance to preservatives in nasal spray, e.g. latex allergy.
- Upper-respiratory tract infection (i.e. a ‘common cold’ resulting in significant nasal congestion) at day of testing (but with the possibility of rescheduling for another time point)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Prosocial behavior using a dictator game task measured at both study visits 35-75 minutes after administration of the investigational medicinal product.
Secondary endpoints 1
- Impulsivity using a delay discounting task, emotion recognition using an emotion recognition task, social learning using an observational fear learning task, and alcohol craving using an alcohol cue-craving task measured at both visits 76-120 minutes after administration of the investigational medicinal product.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Syntocinon 6,7 mikrogram/dos nässpray, lösning
PRD5799944 · Product
- Active substance
- Oxytocin
- Pharmaceutical form
- NASAL SPRAY, SOLUTION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 24 IU international unit(s)
- Max total dose
- 24 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BB02 — OXYTOCIN
- Marketing authorisation
- 6557
- MA holder
- ALFASIGMA S.P.A.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska Institutet
- Sponsor organisation
- Karolinska Institutet
- Address
- Nobels Vag 6
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska Institutet
- Contact name
- Clinical trial information desk
Public contact point
- Organisation
- Karolinska Institutet
- Contact name
- Clinical trial information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 220 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-27 | Sweden | Acceptable 2023-05-16
|
2023-05-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-23 | Sweden | Acceptable 2023-12-19
|
2023-12-19 |