Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT06222749

Oxytocin and Reward Processing in Women

Led by International Research Training Group 2804 · Updated on 2024-02-28

100

Participants Needed

1

Research Sites

149 weeks

Total Duration

On this page

Sponsors

I

International Research Training Group 2804

Lead Sponsor

U

University Hospital Tuebingen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Oxytocin and Reward Processing in Women

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Body-mass index (BMI) between 18 and 28 kg/m2
  • Female sex since birth
  • Normal or corrected vision
  • Natural menstrual cycle or current use of hormonal oral contraceptives
  • For natural menstrual cycle group: no hormonal contraception for at least 6 months and regular cycle between 25 and 31 days
  • For oral contraceptive group: no hormonal contraception for at least 4 months and regular intake of contraceptive pills
Not Eligible

You will not qualify if you...

  • Lack of fluency in German language
  • Smoking
  • Use of medication within the last 6 weeks except for oral contraceptives in the respective group
  • Current neurological or psychiatric disease
  • Current hormonal, metabolic, or chronic diseases such as severe hypertension, diabetes, thyroid dysfunction, or congestive heart failure
  • Pregnancy, delivery, or lactation currently or within the last year
  • Premenstrual dysphoric disorder, endometriosis, or polycystic ovary syndrome
  • Shift work
  • Use of any hormonal treatment or contraception outside study group criteria
  • Contraindications for MRI including non-removable metal objects, incompatible tattoos, pathological hearing, increased noise sensitivity, claustrophobia
  • Surgery less than three months prior
  • Neurological disease or injury
  • Moderate or severe head injury
  • Use of antidepressants or neuroleptics
  • Restricted vision

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Tuebingen; Department of Psychiatry & Psychotherapy; Institute of Medical Psychology and Behavioural Neurobiology

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

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Research Team

M

Manfred Hallschmid, Professor

CONTACT

J

Johannes Klaus, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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