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Examining the effects of intravenous oxytocin infusion on peripheral sensory afferents using microneurography technique in healthy volunteers: a triple-blind, randomized, placebo-controlled trial
EU CTIS ID: 2024-519670-39-00
What this study is testing
To investigate effects of intravenous oxytocin in contrast to placebo on cutaneous mechanoreceptors and its interplay with acute inflammation, cognitive performances, and other subjective measures. We will address this question by measuring oxytocin effects, relative to placebo (saline), in healthy participants using MNG. The primary outcome measure will be the number of action potentials (spikes) generated by AHTMRs and ALTMRs in response to skin indentation after heat-induced experimental inflammation.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-65 years, and willing to provide informed consent
- 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.
- 3. Abstinence 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
- 4. Proficiency in Swedish or English.
- 5. Fertile 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
You likely can't join if
- 1. Hypersensitivity, allergy, or significant reaction to any ingredient of oxytocin (Oxytocin Grindeks®) or NaCl infusion (ATC code: V07AB).
- 10. Use of any illicit drugs (e.g. cannabis, amphetamines).
- 11. History of psychotic experiences and familial history (first and second degree relatives) of psychosis or alcohol use disorder (83)
- 12. Unable to provide a negative urine drug screen (including amphetamines, THC, opiates and benzodiazepines).
- 13. Any 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.
- 14. Subjects with a known latex allergy
See the full eligibility criteria
Who can join
- Age 18-65 years, and willing to provide informed consent
- 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.
- 3. Abstinence 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
- 4. Proficiency in Swedish or English.
- 5. Fertile 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
What rules you out
- 1. Hypersensitivity, allergy, or significant reaction to any ingredient of oxytocin (Oxytocin Grindeks®) or NaCl infusion (ATC code: V07AB).
- 10. Use of any illicit drugs (e.g. cannabis, amphetamines).
- 11. History of psychotic experiences and familial history (first and second degree relatives) of psychosis or alcohol use disorder (83)
- 12. Unable to provide a negative urine drug screen (including amphetamines, THC, opiates and benzodiazepines).
- 13. Any 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.
- 14. Subjects with a known latex allergy
- 15. Subjects with previous high risk of fainting episodes
- 2. Any 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.
- 3. Women 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
- 4. Subjects 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.
- 5. Subjects with past or current history of hyponatremia or at risk for hyponatremia.
- 6. Use 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).
- 7. Any 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.
- 8. Subjects 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).
- 9. Implanted medical devices such as pacemakers.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.