Oxytocin and Reward Processing in Women

NCT06222749 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Menstrual Cycle
  • Hormonal Contraception

Interventions

DRUG

Intranasal oxytocin administration

24 international units (IU) of Syntocinon, nasal spray solution; 1 ml nasal spray contains 40 I.U. oxytocin (equivalent to 67 mcg). One spray hub (0.1 ml) contains 4 I.U. oxytocin (equivalent to 6.7 mcg).

DRUG

Intranasal placebo administration

Nasal spray solution; Placebo will be administered as the placebo controlled condition.

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER
  • German Research Foundation

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • International Research Training Group 2804

    lead OTHER

Principal Investigators

  • Manfred Hallschmid, Professor · Institute of Medical Psychology and Behavioural Neurobiology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06222749 on ClinicalTrials.gov