Oxytocin and Reward Processing in Women (NCT06222749) | Clinical Trial Compass
RecruitingNot Applicable
Oxytocin and Reward Processing in Women
Germany100 participantsStarted 2024-02-16
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxytocin and sex hormone level induced changes in reward-related brain responses in the reward circuitry during effort-based decision making.
Timeframe: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
2
Oxytocin induced changes in reward related behavior.
Timeframe: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
3
Oxytocin induced changes in eating behaviour.
Timeframe: During the experimental session (approximately 4.5 hours).