Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
70
Countries
1
Sites
1
substance use disorder
Investigate the efficacy of Syntocinon in reducing craving for the drug (e.g. heroin, cocaine) in drug dependent individuals and in preventing relapse to drug use
Key facts
- Sponsor
- Fondazione Santa Lucia IRCCS
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2026-05-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Investigate the efficacy of Syntocinon in reducing craving for the drug (e.g. heroin, cocaine) in drug dependent individuals and in preventing relapse to drug use
Secondary objectives 1
- Determine which neural substrate activation pattern underlies drug cue-incubation of craving and whether the identified regions are sensitive to pharmacological treatment with Syntocinon in SUD patients
Conditions and MedDRA coding
substance use disorder
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504518-31-00 | Leveraging the neural mechanisms of social reward for drug relapse prevention | Fondazione Santa Lucia IRCCS |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) Primary diagnosis of substance use disorder according to DSMV criteria 2) Males and non-lactating, non-pregnant females, aged 18-55 years. 3) Patients must be willing and able to give informed consent 4) Patients must have understanding of Italian 5) Patients must provide an identity document
Exclusion criteria 1
- 1) Major psychiatric disorders, such as Schizophrenia, Severe psychosis, Bipolar Affective Disorder, severe Depression with suicidal ideation and intention, Antisocial Personality Disorder and currently symptomatic Anxiety Disorders 2) Pregnant females and those planning a pregnancy; lactating mothers 3) Clinically significant medical condition such as cardiovascular disease (heart disease, heart attacks, abnormally high blood pressure), kidney disease, thyroid disease, epilepsy and brain trauma, that might interfere with the evaluation of the study medication or present a safety concern 4) Nasal cavity pathology (e.g. atrophic rhinitis, previous hypophysectomy, recurrent bleeding, perforation of the nasal septum) 5) Current alcohol use disorder if under pharmacological treatment 7) Any other condition that in the judgement of the investigator would preclude participation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- - Cue-incubation of craving - BOLD fMRI activation signal in the amygdala, insula, ventral striatum and anterior cingulate cortex Timepoint(s) of evaluation of this endpoint Self-report measure of craving following cue exposures at day 7 and day 30 (one week and four weeks into the placebo/Syntocinon treatment period) compared to day 1. BOLD fMRI signal will be evaluated on day 30 compared to day 1.
Secondary endpoints 1
- - Measures of social/emotional cognition evaluated via Picture viewing task, Go/no-go task, Cyberball task and Social Gaze task - Duration of abstinence Timepoint(s) of evaluation of this endpoint Scores will be registered at day 7 and day 30 (one week and four weeks into the placebo/Syntocinon treatment period) compared to day 1. To assess duration of abstinence, drug use will be evaluated at follow ups at 3- and 6-months following termination of treatment period.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Syntocinon 40 IE/ml neusspray, oplossing
PRD5383601 · Product
- Active substance
- Oxytocin
- Pharmaceutical form
- NASAL SPRAY, SOLUTION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 40 IU international unit(s)
- Max total dose
- 40 IU international unit(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- H01BB02 — OXYTOCIN
- Marketing authorisation
- RVG 03716
- MA holder
- ALFASIGMA S.P.A.
- MA country
- Netherlands
- 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
Fondazione Santa Lucia IRCCS
- Sponsor organisation
- Fondazione Santa Lucia IRCCS
- Address
- Via Ardeatina 306
- City
- Rome
- Postcode
- 00179
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Santa Lucia IRCCS
- Contact name
- Daniele Caprioli
Public contact point
- Organisation
- Fondazione Santa Lucia IRCCS
- Contact name
- Daniele Caprioli
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 70 | 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 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2_Protocol_ENGVer2_4 | 2.4 |
| Protocol (for publication) | 2_Protocol_ITAVer2_4 | 2.4 |
| Recruitment arrangements (for publication) | 1_Recruitment arrangements_en | 1 |
| Subject information and informed consent form (for publication) | 3_Consenso_informato_ITAVer3_1_Control | 3.1 |
| Subject information and informed consent form (for publication) | 3_Consenso_informato_ITAVer3_1_Control_SITE NEUTRAL | 1 |
| Subject information and informed consent form (for publication) | 3_Consenso_informato_ITAVer3_1_Patient | 3.1 |
| Subject information and informed consent form (for publication) | 3_Consenso_informato_ITAVer3_1_Patient_SITE NEUTRAL | 1 |
| Subject information and informed consent form (for publication) | 4_CE_SPERIM_MOD_5_3.0 | 3.0 |
| Subject information and informed consent form (for publication) | 4_CE_SPERIM_MOD_5_SITE NEUTRAL 3.0 | 3.0 |
| Subject information and informed consent form (for publication) | 6_CRF_List of variables collected | 1 |
| Subject information and informed consent form (for publication) | Allegato 1_1 | 1 |
| Subject information and informed consent form (for publication) | Allegato 2_1 | 1 |
| Subject information and informed consent form (for publication) | Allegato 3_1 | 1 |
| Subject information and informed consent form (for publication) | Allegato 4 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Syntocinon_13_3 | 1 |
| Synopsis of the protocol (for publication) | 1_Sinossi_trial clinico | 1 |
| Synopsis of the protocol (for publication) | Synopsis of clinical trial | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-25 | Italy | Acceptable 2026-04-22
|
2026-05-29 |