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NCT Number: NCT06284382

Interaction Between Early Trauma and Odor-induced Dopamine Release

This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The occurrence of early trauma has been linked to alterations in the development of emotion regulation circuits and functional brain connectivity (particularly in the dorsolateral prefrontal cortex - DLPFC), the dopaminergic response to stress and an alteration in hedonicity (including olfactory hedonicity), which can lead to the onset of psychiatric disorders such as anxiety or depression.

However, few studies have investigated the influence of early trauma on the release of dopamine (DA) evoked by odors with a positive emotional valence. Yet hedonicity is a key component of olfaction, as a positive odor leads to reinforced behavior in areas such as food intake and social interaction. This reinforcement process is thought to be underpinned by the very close link between the olfactory system (olfactory tubercle), the emotional regulation system (DLPFC) and the reward system (striatum), including the release of DA.

The aim of the study is to investigate the influence of early trauma on DAergic transmission evoked by odorants with a positive emotional valence.

To this end, 30 participants will be recruited and divided into two groups: those with early trauma and those without, according to their score on the Childhood Trauma Questionnaire. They will undergo an MRI-PET scan during which they will be exposed to pleasant odors. Subcortical dopaminergic transmission will be analyzed using the PET activity of [11C]Raclopride (a D2 receptor antagonist).

Investigators hypothesize that early trauma resulting in abnormal cortico-subcortical and cortico-cortical connectivity would lead to a deficit in the hedonic appreciation of a pleasant odor, associated with a reduction in DAergic reactivity evoked in the reward system.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Have been selected based on the Childhood Trauma Questionnaire score
  • Non-smoker
  • Be able to speak and read French
  • Sign a consent form before intervention.

Exclusion criteria

  • A pre-existing condition that affects olfaction including congenital anosmia, upper respiratory tract infection, nasal and/or sinus disease,
  • Be on medication, with the exception of oral contraceptives
  • Pregnant or breast-feeding woman (check with urine pregnancy tests);
  • Contraindications to TMS or MRI (implanted medical devices or metallic foreign body in the head);
  • Psychiatric disorders
  • Use of psychotropic drugs
  • Have participated in a study involving the injection of a radiotracer during the year

Treatment and study plan

High score at Childhood Trauma Questionnaire.

Other

In the "presence of early trauma" arm, 15 participants are recruited based on a high Childhood Trauma Questionnaire total score.

Low score at Childhood Trauma Questionnaire.

Other

In the "absence of early trauma" arm, 15 participants are recruited based on a low Childhood Trauma Questionnaire total score.

Primary outcomes

  1. Dopamine transmission measured with positron emission tomography

    Time frame: 24 months

    Subcortical dopaminergic transmission will be analyzed, using [11C]raclopride PET activity (D2 receptor antagonist)

Secondary outcomes

  1. Odor hedonic appreciation.

    Time frame: 24 months

    The pleasantness of the odors presented will be assessed on a scale of 1 to 9.

  2. Functional brain connectivity.

    Time frame: 24 months

    Resting-state functional connectivity assessed with fMRI.

  3. Effective brain connectivity

    Time frame: 24 months

    Effective brain connectivity will be assessed using a dual-coil TMS protocol that stimulates the motor cortex and dorsolateral prefrontal cortex during odor presentation. Measurement of the amplitude of the motor response reflects the connectivity between these two regions of interest.

Study contacts

Contact information is provided by the study sponsor or research team.

FILIPE GALVAO

CONTACT

[email protected]

0033437915565

VERONIQUE VIAL

CONTACT

[email protected]

0033437915522

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Consequence of Early Trauma on Odor Hedonics Appreciation and DOpamine Release

Acronym: T-ODOR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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