OXYTOCIN for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Age 18-65 years, and willing to provide informed consent"}
• {"criterion_text":"- Good health as determined by medical history, ECG, and clinical assessment of lab tests. The final decision regarding inclusion will be according to the judgment of the lead physician."}
• {"criterion_text":"- 3.\tAbstinence from recreational/illicit or medical substances (including amphetamines, cannabis, opiates and benzodiazepines) 24 hours before and during the experiment, as determined by medical history and clinical assessment of blood samples and urine toxicology tests. Furthermore, the participant are expected to refrain from caffeine, alcohol, and nicotine for a minimum of 12 h before the experiment, based on previous recommendation (76), as well as to avoid any potential drug-drug interactions and influence on cognitive and physiological measures"}
• {"criterion_text":"- 4.\tProficiency in Swedish or English."}
• {"criterion_text":"- 5.\tFertile females must have a negative urine pregnancy test (hCG) at the start of the 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"}

Exclusion criteria

• {"criterion_text":"- 1.\tHypersensitivity, allergy, or significant reaction to any ingredient of oxytocin (Oxytocin Grindeks®) or NaCl infusion (ATC code: V07AB)."}
• {"criterion_text":"- 10.\tUse of any illicit drugs (e.g. cannabis, amphetamines)."}
• {"criterion_text":"- 11.\tHistory of psychotic experiences and familial history (first and second degree relatives) of psychosis or alcohol use disorder (83)"}
• {"criterion_text":"- 12.\tUnable to provide a negative urine drug screen (including amphetamines, THC, opiates and benzodiazepines)."}
• {"criterion_text":"- 13.\tAny other condition due to which, in the judgment of the PI or designee, participation in the study is not in the subject’s best interest or is unlikely to yield valid data."}
• {"criterion_text":"- 14.\tSubjects with a known latex allergy"}
• {"criterion_text":"- 15.\tSubjects with previous high risk of fainting episodes"}
• {"criterion_text":"- 2.\tAny clinically significant medical condition as determined by interview of the research nurse and lab test performed during screening visit, or any disease, diagnosis, or condition (medical or surgical) including immunosuppression that, in the opinion of the PI, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject’s compliance with study procedures, or compromise the quality of the data."}
• {"criterion_text":"- 3.\tWomen who are pregnant (positive result for urine pregnancy test at screening visit), women who are currently nursing or lactating, or women that have been pregnant within 2 years"}
• {"criterion_text":"- 4.\tSubjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis. Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval."}
• {"criterion_text":"- 5.\tSubjects with past or current history of hyponatremia or at risk for hyponatremia."}
• {"criterion_text":"- 6.\tUse of prescription or over-the-counter drugs that could interfere with the clinical effects of oxytocin or exacerbate side effects of oxytocin, including taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI’s, MAOI, the recreational drug ecstasy or CNS-active medications. Furthermore, clinically relevant CYP3A4 inhibitors (such as clarithromycin, itraconazole, ketoconazole, posaconazole, diltiazem, erythromycin, fluconazole, voriconazole, verapamil and grapefruit juice) or CYP3A4 inducers (such as phenobarbital, phenytoin, carbamazepine, rifampicin, glucocorticoids and St. John's Wort) that potentially affects the level or activity of oxytocin (77)."}
• {"criterion_text":"- 7.\tAny medical condition that, in the judgment of the PI or designee and after appropriate consultation if needed, is likely to influence neuronal activities, information processing, oxytocin level/activity or somatosensation."}
• {"criterion_text":"- 8.\tSubjects with substance use disorders or any other psychiatric 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; (78), as assessed by PI or designee. Patients will be screened using a urine drug screening test, MMS (79), the Drug DUDIT (80), and AUDIT (81). The results and their clinical significance will ultimately be evaluated by a trained healthcare professional (nurse or physician). If indication is obtained that a clinically significant psychiatric disorder may be present, a full Mini-International Neuropsychiatric Interview (MINI) will be carried out by appropriately trained staff (82)."}
• {"criterion_text":"- 9.\tImplanted medical devices such as pacemakers."}

Primary endpoints

• {"endpoint_text":"- •\tSingle afferent neuronal response (i.e., number of spike) of afferents to test filaments (1000 and 20 mN after heat-inflammation in AHTMRs and in LTMRs, respectively (see details under 10.2.1).","definition_or_measurement_approach":"Primary outcome measure defined as the number of action potentials (spikes) generated by AHTMRs and ALTMRs in response to skin indentation after heat-induced experimental inflammation; measured using microneurography (MNG) with specified test filaments (1000 and 20 mN)."}

Secondary endpoints

• {"endpoint_text":"- •\tPsychophysics I: Psychophysical quantification of touch pleasantness","definition_or_measurement_approach":"Psychophysical quantification of touch pleasantness using psychophysical measurements (methods described in protocol)."}
• {"endpoint_text":"- •\tPsychophysics I: Psychophysical quantification of inflammation","definition_or_measurement_approach":"Psychophysical quantification of inflammation using psychophysical assessments before and after heat-induced inflammation."}
• {"endpoint_text":"- •\tMeasuring the scores on cognitive performances (information processing speed accuracy, scores on learning and memory, and maximum scores and total scores on verbal WM) contrasting oxytocin with saline infusion","definition_or_measurement_approach":"Cognitive performance measured using tasks for information processing speed, learning and memory, and verbal working memory; scores compared between oxytocin and saline infusion arms."}

Sweden

Earliest CTIS Part Ii Submission Date

18-02-2025

Latest Decision Or Authorization Date

14-04-2025

Processing Time Days

55

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Linkopings Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden