Clinical trial • Phase II|Phase IV • Neurology

Ketamine for Opioid use disorder

Phase II|Phase IV trial of Ketamine for Opioid use disorder. 20 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Opioid use disorder
Trial Stage
Phase II|Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-01-2025
First CTIS Authorization Date
29-01-2025

Trial design

Phase II|Phase IV trial across 1 site in Cyprus.

Target Sample Size
20

Eligibility

Recruits 20 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults aged 18-65. Subject information and informed consent form is listed in the documents..

Pregnancy Exclusion
Pregnancy (positive urine screen)
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults aged 18-65. Subject information and informed consent form is listed in the documents.

Inclusion criteria

  • {"criterion_text":"- Age between 18 to 65 years old"}
  • {"criterion_text":"- Currently into maintenance treatment for opioid use disorder"}
  • {"criterion_text":"- Patient Health Questionnaire-9 score of ≥ 10"}
  • {"criterion_text":"- Primary Care-PTSD-5 Screen ≤ 2"}

Exclusion criteria

  • {"criterion_text":"- ECG findings showing: Tachycardia, Prior myocardial infarction, Myocardial ischemia, Aberrant conduction"}
  • {"criterion_text":"- Hypertension (defined as): Systolic blood pressure > 140 mmHg; or Diastolic blood pressure > 90 mmHg"}
  • {"criterion_text":"- Pregnancy (positive urine screen)"}
  • {"criterion_text":"- Inaccessible veins for phlebotomy/infusion procedures"}
  • {"criterion_text":"- Liver function abnormalities: Baseline alkaline phosphatase > 2.5 times upper limit of normal; Baseline aspartate aminotransferase > 3 times upper limit of normal"}
  • {"criterion_text":"- Current bipolar disorder (DSM-5 criteria)"}
  • {"criterion_text":"- Current or history of psychotic spectrum disorders"}
  • {"criterion_text":"- Current or previous recreational use of ketamine or PCP"}
  • {"criterion_text":"- Active suicidal ideation (score >4 on item 10 of the MADRS assessment)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Reversal of comorbid negative affective behaviors","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Prolongation/maintenance of abstinence in OUD patients","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Reduction in cravings","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Identification of predictive biomarkers: (i) Emotion regulation ability; (ii) Stress response biomarkers; (iii) Changes in neural activity","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Association between ketamine-induced changes in brain activity and treatment outcomes","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
20
Recruitment Window Months
61
Consent Approach
Informed consent obtained from participants; a subject information and informed consent form is listed in the documents. Participants are adults (18-65). No details on assent or languages are provided.

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Cyprus

Earliest CTIS Part Ii Submission Date
27-01-2025
Latest Decision Or Authorization Date
29-01-2025
Processing Time Days
2
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
State Health Services Organisation
Department Name
Mental Health Services
Contact Person Name
Dimos Fotopoulos
Contact Person Email
dim.fotopoulos@shso.org.cy

Sponsor

Primary sponsor

Full Name
University of Cyprus
Organisation Type
Educational Institution
Country Of Registered Address
Cyprus

Investigational products

Investigational Product Name
KETAMINE
Active Substance
Ketamine
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
Max daily dose 0.5 mg/kg; max total dose 3 mg/kg
Combination Treatment
Yes

Related trials

Other published trials that may interest you.