Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
84
Countries
1
Sites
1
Healthy adults aged 18-30.
Primary objective: to assess whether paracetamol can reduce negative affective experiences compared to placebo over 7 days of treatment.
Key facts
- Sponsor
- Oslo Metropolitan University
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Psychological Phenomena [F02]
- Decision date (initial)
- 2026-01-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ministry of Education and Research, Norway · Johanne og Einar Eilertsens forskningsfond til sønnen Johan Eilertsens minne
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy
Primary objective: to assess whether paracetamol can reduce negative affective experiences compared to placebo over 7 days of treatment.
Secondary objectives 1
- To assess whether paracetamol affects neurophysiological functioning in general and specifically related to emotion processing and stress, and if paracetamol affects anxiety, stress, depression and insomnia symptoms over the study period.
Conditions and MedDRA coding
Healthy adults aged 18-30.
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Eva Hilland [email protected] or Shervin Bukhari [email protected].
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-522753-19-01 | Exploring the Psychoactive Effects of Paracetamol: A parallel group, basic science, double blind, two armed study, to investigate potential emotional and cognitive effects of paracetamol (tablet form) compared to a placebo (tablet form) in healthy male and female participants between ages 18 and 30. | Oslo Metropolitan University |
| 2025-522753-19-00 | Exploring the Psychoactive Effects of Paracetamol: A parallel group, basic science, double blind, two armed study, to investigate potential emotional and cognitive effects of paracetamol (tablet form) compared to a placebo (tablet form) in healthy male and female participants between ages 18 and 30. | Oslo Metropolitan University |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age: 18-30
- Participants who are overtly healthy as determined by self-report and blood tests
- Weight: Body weight within 45 – 120 kg and Body Mass Index within the range 18.5 – 30 kg/m2
- Contraceptives: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Informed Consent: Capable of giving signed informed consent as described in Appendix 1. which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Language: Able to communicate fluently in Norwegian, as this will be the language in which study material, including the ICF is written in.
Exclusion criteria 7
- Allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6, package insert).
- Chronic pain condition
- Currently being evaluated for, or undergoing treatment for medical/physical, psychological condition(s) or neuropsychiatric diagnoses
- Acute inflammation of the liver (hepatitis)
- Previous or current liver injury or kidney injury
- Pregnancy
- BMI ≤18.5 kg/m2 or BMI>30
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Self-reported negative affect as measured with PANAS over the intervention period.
Secondary endpoints 9
- To assess whether paracetamol affects neurophysiological functioning in general and specifically related to emotion processing and stress, and if paracetamol affects anxiety, stress, depression and insomnia symptoms over the study period.
- • Self-reported positive affect as measured with PANAS over the intervention period.
- Anxiety score (BAI-II) measured on the 7th day
- Depression score (BDI-II) measured on the 7th day
- Perceived stress scale (PSS score) measured on the 7th day
- Sleep, measured by Pittsburg Sleep Scale (PSQ-I score) on the 7th day
- EEG: LPP response to emotional stimuli measured in the Emotional Interrupt Task
- EEG: Resting state EEG dynamics Self-reported and evoked physiological stress response in the Montreal Imaging Stress Task (MIST).
- Biomarkers: Change of IL-6 and IL-8 during intervention period.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Paracetamol Norfri 500 mg filmdrasjerte tabletter.
PRD11772878 · Product
- Active substance
- Paracetamol
- Substance synonyms
- ACETAMINOPHEN
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 17-11571
- MA holder
- EVOLAN PHARMA AB
- MA country
- Norway
- 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
Oslo Metropolitan University
- Sponsor organisation
- Oslo Metropolitan University
- Address
- Postboks 4 St Olavs plass
- City
- Oslo
- Postcode
- 0130
- Country
- Norway
Scientific contact point
- Organisation
- Oslo Metropolitan University
- Contact name
- Eva Hilland
Public contact point
- Organisation
- Oslo Metropolitan University
- Contact name
- Eva Hilland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 84 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | BAI | 1 |
| Protocol (for publication) | BDI-II_NO_modified_weekly | 1 |
| Protocol (for publication) | D1_Protocol_2025-522753-19-02 | 3 |
| Protocol (for publication) | D1_Protocol_2025-522753-19-02 V3 track changes | 1 |
| Protocol (for publication) | PANAS_NO | 1 |
| Protocol (for publication) | Pittsburgh Sleep Quality Index_NO_modified | 1 |
| Protocol (for publication) | PSS_10_no_modified_weekly | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material description | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description track changes | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paracetamol Norfri | 1 |
| Synopsis of the protocol (for publication) | D1 _Protocol synopsis Norwegian 2025-522753-19-02 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-24 | Norway | Acceptable 2026-01-26
|
2026-01-27 |