Oxytocin and Reward Processing in Women

NCT06222749 | Recruiting

• 1 other identifier: IRTG_P06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Cycle; Hormonal Contraception

Keywords

Oxytocin; Intranasal oxytocin; magnetic resonance imaging; MRI; fMRI; energy homeostasis; metabolism; reward processing; motivation; menstrual cycle; hormonal contraceptives; sex hormones; eating behavior; women's mental health

Outcome Measures

Primary Outcomes (3)

• Oxytocin and sex hormone level induced changes in reward-related brain responses in the reward circuitry during effort-based decision making.

  Comparing brain activity (BOLD signals) in the reward circuitry (ROIs: nucleus accumbens, putamen, caudate, ventral tegmental area, amygdala, ventromedial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex, insula) and cognitive control areas (ROIs: dorsolateral and ventromedial prefrontal cortex, anterior cingulate cortex, supplementary motor area) of female participants in luteal menstrual cycle phase, follicular menstrual cycle phase, with combined OC intake and progestogen-only OC intake during a reward task with oxytocin vs placebo.

  During neuroimaging (60 minutes) oxytocin compared to placebo condition.

• Oxytocin induced changes in reward related behavior.

  Force exerted on grip force controller to obtain rewards and changes in behavioral parameters measured during the Effort Allocation Task after oxytocin vs. placebo administration.

  During neuroimaging (60 minutes) oxytocin compared to placebo condition.

• Oxytocin induced changes in eating behaviour.

  Number of consumed calories (kcal) in a snack test and subjective satiety in oxytocin vs. placebo condition.

  During the experimental session (approximately 4.5 hours).

Secondary Outcomes (3)

• Oxytocin induced changes in functional connectivity.

  During neuroimaging (60 minutes) oxytocin compared to placebo condition.

• Oxytocin induced changes in stress-axis reactivity.

  During the experimental session (approximately 4.5 hours).

• Sex hormone induced changes in energy expenditure.

  Measured in each experimental session, approximately 4 weeks apart; between-subject outcome

Study Arms (4)

NC follicular

EXPERIMENTAL

Naturally cycling, healthy women in the follicular menstrual cycle phase.

Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration

NC luteal

EXPERIMENTAL

Naturally cycling, healthy women in the luteal menstrual cycle phase.

Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration

OC combined

EXPERIMENTAL

Healthy women taking combined oral hormonal contraceptives.

Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration

OC progestogen-only

EXPERIMENTAL

Healthy women taking progestogen-only oral hormonal contraceptives.

Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration

Interventions

Intranasal oxytocin administration DRUG

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).

Also known as: Syntocinon

NC follicular; NC luteal; OC combined; OC progestogen-only

Intranasal placebo administration DRUG

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

Also known as: Placebo

NC follicular; NC luteal; OC combined; OC progestogen-only

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Research Training Group 2804: lead
• University Hospital Tuebingen: collaborator
• German Research Foundation: collaborator
• Uppsala University: collaborator

Study Sites (1)

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

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Manfred Hallschmid, Professor

  Institute of Medical Psychology and Behavioural Neurobiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Hallschmid, Professor

CONTACT

+49 7071 29 88925; manfred.hallschmid@uni-tuebingen.de

Johannes Klaus, MD

CONTACT

Johannes.Klaus@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participants nor investigators will know at which time point the participant will receive intranasal oxytocin and placebo. The nasal sprays will be prepared by independent members of the university hospital Tübingen.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will assess the effects of oxytocin administration on reward processing and metabolism using a double-blind randomized cross-over design. In a within subject design, participants will get receive both oxytocin and placebo (both conditions) at different time points (approximately 4 weeks apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional magnetic resonance imaging (fMRI)) during an effort-based decision-making task.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 25, 2024
• Study Start: February 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available after an embargo period of 12 months after completion of the study.
• Access Criteria: Until the data is publicly available, researchers may contact the lead PI to gain access.

Locations

DE (1)