The influence of pain-killing associative learning in the body after repeated ketamine exposure in patients with Fibromyalgia Syndrome

Phase 1

• Conditions: Fibromyalgia Syndrome; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2019-004812-73-NL
• Lead Sponsor: eiden University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

-Diagnosed with FMS by a rheumatologist
- Females
-Age between 18 and 75 years old
-Dutch speaking participants

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-A medical diagnosis other than fibromyalgia explaining the chronic pain symptoms.
-Presence of hypertension or any other severe cardiovascular co-morbidity (e.g., heart failure (NYHA III or IV), neuromuscular diseases, pulmonary obstructive & restrictive diseases, kidney failure (eGFR = 60), liver diseases or epilepsy)
-Presence of any severe psychiatric disease not related to symptoms of FMS (e.g., schizophrenia, schizoaffective disorders, severe anxiety or depression (HADS > 15), bipolar disorder, dissociative personality disorder, or (previous) addiction to strong analgesics.
-Presence of any allergy for S(+)-ketamine, midazolam, ondansetron or flumazenil
-Long term use of medicine that is contra-indicated when administering S(+)-ketamine or midazolam: NMDA-receptor antagonists, parasympathomimetics (e.g., bronchodilators), thyroid hormones, vasopressin, CYP3A4 liver enzyme inhibitors (e.g., verapamil, diltiazem, or certain antibiotics), CYP3A4 liver enzyme inductors (e.g., rifampicin, carbamazepine, fenytoin), and strong opioids (e.g., morphine, fentanyl, heroin)
-Previous experience(s) with S(+)-ketamine in a medical setting or previous experience with recreational racemic Ketamine use.
-Use of painkillers different than usual dose of treatment on the day of experimentation.
-Use of alcohol or drugs 24 hours prior to the hospital visits
-Use of caffeine 12 hours prior to the hospital visits
-Body weight > 100kg or BMI >35
-Presence of pregnancy or lactation
-Presence of an ICD, pacemaker or implanted medication pump
-Presence of chronic pain at the local site of experimental pain stimuli or monitoring devices.
-Implanted materials in either arm (e.g., non-removable piercings)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified