Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
36
Countries
1
Sites
1
Healthy volunteers
The primary objective of the study is to determine the effects of the prototypical opioid morphine on the neural, physiological, and subjective response to emotional distress of rejection in healthy controls.
Key facts
- Sponsor
- Linkopings Universitet
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 20 Apr 2022 → ongoing
- Decision date (initial)
- 2024-10-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Swedish Research Council
External identifiers
- EU CT number
- 2024-517855-10-00
- EudraCT number
- 2019-004703-13
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
The primary objective of the study is to determine the effects of the prototypical opioid morphine on the neural, physiological, and subjective response to emotional distress of rejection in healthy controls.
Secondary objectives 1
- The secondary objective is to examine morphine effects on the neural, physiological, and behavioral response to social approach and avoidance
Conditions and MedDRA coding
Healthy volunteers
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period 1 Within-subject, counterbalanced experimental medicine
|
Randomised Controlled | Double | [{"id":86736,"code":1,"name":"Subject"},{"id":86737,"code":2,"name":"Investigator"},{"id":86738,"code":4,"name":"Analyst"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Age 18-65 years, and willing to provide informed consent.
- Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include potassium, creatinine, hemoglobin, glucose, calcium, BUN, complete blood count, total bilirubin, AST, ALT, and GGT. The final decision will be according to the judgment of the lead physician.
- Proficiency in Swedish
- Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.
- Participant must be willing to receive two IV lines and undergo an MR scan
- Right-handedness assessed by the Edinburgh Handedness Inventory (EHI)
- Prior experience with medical opioids (at least one experience with opiates such as oxycodone, morphine, hydrocodone, codeine, or dihydrocodeine).
Exclusion criteria 9
- Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine (defined in DSM-5 terms as Substance Use Disorder, Moderate or Severe). Patients will be screened using the Modified Mini Screen (MMS), the Drug Use Disorder Identification Test (DUDIT), a urine drug screening, and the Alcohol Use Disorder Identification Test (AUDIT). The results and their clinical significance will ultimately be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If indication is obtained that a clinically significant psychiatric disorder may be present, a full MINI interview will be carried out by appropriately trained staff.
- Significant adverse reaction to prior opioid exposure.
- Any current use of CNS-active medications.
- Current use of opioid analgesics, opioid use for > 6 weeks (lifetime), or within the 3 months prior to study enrollment.
- Unable to provide a negative urine drug screen (THC, amphetamine, methamphetamine, opioids, benzodiazepines, cocaine, buprenorphine, methadone, tramadol, oxycontin, fentanyl and clonazepam).
- Moderate to strong nicotine use (>14 cigarettes/week, or corresponding level of other nicotine delivering vehicles) assessed by the Fagerström Test for Nicotine Dependence (FTND).
- Pregnancy, intention to become pregnant, or breastfeeding a child.
- Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Subjective distress to exclusion (Visual analog scale).
- Neural response to social exclusion (fMRI BOLD-signal).
Secondary endpoints 2
- Morphine effects on behavioral, psychophysiological, and neural responses to personal distance and social approach and avoidance within group.
- Rejection-induced distress effects on stress-related biomarkers (e.g., cortisol and endocannabinoid levels) and its interaction with morphine.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Morfin Abcur, 10 mg/ml, injektionsvätska, lösning
PRD11648241 · Product
- Active substance
- Morphine Hydrochloride
- Substance synonyms
- MORPHINI HYDROCHLORIDUM
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 mg/kg milligram(s)/kilogram
- Max total dose
- 0.2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 45658
- MA holder
- ABCUR AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
0.9% Sodium Chloride Intravenous Infusion Solution
PRD10683437 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1 millilitre(s)/kilogram
- Max total dose
- 2 millilitre(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- PA1968/018/001
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Linkopings Universitet
- Sponsor organisation
- Linkopings Universitet
- Address
- Sandbacksgatan 7, Linkopings Domkyrkofors. Linkopings Domkyrkofors.
- City
- Linkoping
- Postcode
- 582 25
- Country
- Sweden
Scientific contact point
- Organisation
- Linkopings Universitet
- Contact name
- Markus Heilig
Public contact point
- Organisation
- Linkopings Universitet
- Contact name
- Markus Heilig
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2022-04-20 | 2022-04-22 | 2025-07-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 20240830 Protocol MOR-STRESS -SI | 1 |
| Recruitment arrangements (for publication) | Annons 24-03-12_QR | 1 |
| Subject information and informed consent form (for publication) | 2023-09-04_Forskningspersonsinformation v10_clean | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Morphine | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-13 | Sweden | Acceptable 2024-10-25
|
2024-10-25 |