Overview
Sponsor-declared trial summary
Opioid Use Disorder
The primary objective of this study is to evaluate the efficacy of adjunctive ketamine in reducing depressive symptom severity in individuals with opioid use disorder receiving methadone or buprenorphine/naloxone (suboxone) maintenance treatment.
Key facts
- Sponsor
- University of Cyprus
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Research and Innovation Foundation (RIF) Cyprus
External identifiers
- EU CT number
- 2025-520843-34-00
- EudraCT number
- 2022-001997-70
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary objective of this study is to evaluate the efficacy of adjunctive ketamine in reducing depressive symptom severity in individuals with opioid use disorder receiving methadone or buprenorphine/naloxone (suboxone) maintenance treatment.
Secondary objectives 1
- A secondary objective is to identify stress-related and neurophysiological biomarkers associated with treatment response and relapse vulnerability, in order to better understand the biological mechanisms underlying clinical outcomes.
Conditions and MedDRA coding
Opioid Use Disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age between 18 to 65 years old
- Currently into maintenance treatment for opioid use disorder
- Patient Health Questionnaire-9 score of ≥ 10
- Primary Care-PTSD-5 Screen ≤ 2
Exclusion criteria 9
- ECG findings showing: Tachycardia, Prior myocardial infarction, Myocardial ischemia, Aberrant conduction
- Hypertension (defined as): Systolic blood pressure > 140 mmHg; or Diastolic blood pressure > 90 mmHg
- Pregnancy (positive urine screen)
- Inaccessible veins for phlebotomy/infusion procedures
- Liver function abnormalities: Baseline alkaline phosphatase > 2.5 times upper limit of normal; Baseline aspartate aminotransferase > 3 times upper limit of normal
- Current bipolar disorder (DSM-5 criteria)
- Current or history of psychotic spectrum disorders
- Current or previous recreational use of ketamine or PCP
- Active suicidal ideation (score >4 on item 10 of the MADRS assessment)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Reversal of comorbid negative affective behaviors
- Prolongation/maintenance of abstinence in OUD patients
- Reduction in cravings
Secondary endpoints 2
- Identification of predictive biomarkers: (i) Emotion regulation ability; (ii) Stress response biomarkers; (iii) Changes in neural activity
- Association between ketamine-induced changes in brain activity and treatment outcomes
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB08365MIG · Substance
- Active substance
- Ketamine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.5 mg/kg milligram(s)/kilogram
- Max total dose
- 3 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University of Cyprus
- Sponsor organisation
- University of Cyprus
- Address
- Panepistimiou 1
- City
- Aglantzia
- Postcode
- 2109
- Country
- Cyprus
Scientific contact point
- Organisation
- University of Cyprus
- Contact name
- Panos Zanos
Public contact point
- Organisation
- University of Cyprus
- Contact name
- Panos Zanos
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Cyprus | Authorised, recruitment pending | 20 | 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 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | Ketamine Protocol-01-Not to be published | 1 |
| Protocol (for publication) | Ketamine Protocol-01- To be published | 1 |
| Recruitment arrangements (for publication) | Blanc | 1 |
| Subject information and informed consent form (for publication) | 03 information and consent form_to be published | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ketamin_10 ml_EN_PIL_SmPC Juli 21 beglaubigt | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Cyprus | Acceptable with conditions 2025-01-28
|
2025-01-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-17 | Cyprus | Acceptable with conditions 2025-01-28
|
2026-02-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-17 | Cyprus | Acceptable with conditions 2025-01-28
|
2026-02-17 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-02 | Acceptable with conditions 2025-01-28
|