Investigating the effects of oxytocin on reward processing in women
The Role of Oxytocin in Reward Processing Across the Menstrual Cycle and With Oral Contraceptive Use
NA · International Research Training Group 2804 · NCT06222749
This study is testing how oxytocin affects how women respond to rewards and their metabolism, looking at different groups based on their hormonal status.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | International Research Training Group 2804 (other) |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Trial ID | NCT06222749 on ClinicalTrials.gov |
What this trial studies
This study examines how oxytocin influences reward processing and metabolic functions in women across different hormonal statuses. It involves four groups of women: those with natural menstrual cycles in both the follicular and luteal phases, and those taking combined or progestogen-only hormonal contraceptives. Participants will undergo MRI scans and cognitive tests after receiving either intranasal oxytocin or a placebo in a randomized, double-blind design. Blood samples will be collected to analyze hormone levels and assess body composition.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-35 with a normal body mass index and either a natural menstrual cycle or stable hormonal contraceptive use.
Not a fit: Patients with current neurological or psychiatric diseases, or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how hormonal variations affect reward processing, potentially leading to better treatments for related conditions.
How similar studies have performed: While studies on oxytocin's effects have been conducted, this specific focus on women and hormonal interactions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tübingen, Baden-Wurttemberg
- University of Tuebingen; Department of Psychiatry & Psychotherapy; Institute of Medical Psychology and Behavioural Neurobiology — Tübingen, Baden-Wurttemberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Manfred Hallschmid, Professor — Institute of Medical Psychology and Behavioural Neurobiology
- Study coordinator: Manfred Hallschmid, Professor
- Email: manfred.hallschmid@uni-tuebingen.de
- Phone: +49 7071 29 88925
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menstrual Cycle, Hormonal Contraception, Oxytocin, Intranasal oxytocin, magnetic resonance imaging, MRI, fMRI, energy homeostasis