NCT06222749 Oxytocin and Reward Processing in Women
| NCT ID | NCT06222749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Research Training Group 2804 |
| Condition | Menstrual Cycle |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-16 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-02-16 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Oxytocin is a hypothalamic neuropeptide that is best known for its peripheral physiological effects in the female organism i.e., uterine contractions during birth. The neuropeptide furthermore affects reward processing and metabolic functions such as eating behavior and body weight. Oxytocin receptors are present in brain regions associated with the processing of rewards, e.g., ventral tegmental area (VTA), nucleus accumbens (NAcc) and nucleus stria terminalis. Previous studies indicate that oxytocin interacts with sex hormones such as estradiol in a sex-specific manner. Despite known sex differences in oxytocin function, most studies i.e., on the metabolic effects of oxytocin in humans have so far focused on young, healthy men. Intranasal oxytocin administration has emerged as a method to experimentally investigate central nervous effects of oxytocin in the absence of relevant side effects. In the proposed study the investigators aim to systematically investigate the acute effect of intranasal oxytocin on reward processing in relation to circulating and synthetic sex hormones in healthy, naturally cycling women and in women taking hormonal oral contraceptive pills. The investigators will administer 24 international units (IU) of intranasal oxytocin vs. placebo and investigate neural correlates in a 3T MRI scanner including functional imaging during a reward processing task, changes in brain anatomy and connectivity. Additionally, metabolic functions, eating behavior and changes in mood and wellbeing will be assessed and blood will be drawn to assess parameters of hormonal and metabolic status.
Eligibility Criteria
Inclusion Criteria: * Body-mass index (BMI): 18-28 kg/m2 * Sex: female (since birth) * Normal or corrected vision * Natural menstrual cycle (NC) or intake of hormonal oral contraceptives (OC) * NC: No hormonal contraception for at least 6 months; regular menstrual cycle (between 25 and 31 days) prior to participation * OC: No hormonal contraception for at least 4 months, regular intake of OC pill Exclusion Criteria: * No German language fluency (due to German language test content) * Smoking * Medication taken within the last 6 weeks (except for OCs in the respective group) * Current neurological or psychiatric disease (anamnestic survey) * Current medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure) * Pregnancy, delivery and lactation (current and within the last year; anamnestic survey, current pregnancy test) * Premenstrual dysphoric disorder (PMDD), endometriosis or polycystic ovary syndrome (PCOS) * Shift work * NC: Any kind of hormonal treatment or contraception * OC: Any kind of hormonal treatment or contraception (except OCs) * Contraindication for MRI: * Non-removable metal objects on or in the body * Tattoos (if MRI-incompatible according to expert guidelines) * Pathological hearing or increased sensitivity to loud noise * Claustrophobia * Operation less than three months ago * Neurological disease or injury * Moderate or severe head injury * Intake of antidepressants or neuroleptics * Restricted vision
Contact & Investigator
Manfred Hallschmid, Professor
PRINCIPAL INVESTIGATOR
Institute of Medical Psychology and Behavioural Neurobiology
Frequently Asked Questions
Who can join the NCT06222749 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Menstrual Cycle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06222749 currently recruiting?
Yes, NCT06222749 is actively recruiting participants. Contact the research team at manfred.hallschmid@uni-tuebingen.de for enrollment information.
Where is the NCT06222749 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT06222749 clinical trial?
NCT06222749 is sponsored by International Research Training Group 2804. The principal investigator is Manfred Hallschmid, Professor at Institute of Medical Psychology and Behavioural Neurobiology. The trial plans to enroll 100 participants.