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Recruiting NCT06284382

Interaction Between Early Trauma and Odor-induced Dopamine Release

No phase Interventional Trauma, Psychological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High score at Childhood Trauma Questionnaire., Low score at Childhood Trauma Questionnaire..
Who it may be relevant to
Registry conditions: Trauma, Psychological. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Consequence of Early Trauma on Odor Hedonics Appreciation and DOpamine Release

Overview

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

Detailed description

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.

Interventions

  • Other High score at Childhood Trauma Questionnaire.
    In the "presence of early trauma" arm, 15 participants are recruited based on a high Childhood Trauma Questionnaire total score.
  • Other Low score at Childhood Trauma Questionnaire.
    In the "absence of early trauma" arm, 15 participants are recruited based on a low Childhood Trauma Questionnaire total score.

Primary outcome measures

  • Dopamine transmission measured with positron emission tomography [Time frame: 24 months]
Secondary outcome measures (3)
  • Odor hedonic appreciation. [Time frame: 24 months]
  • Functional brain connectivity. [Time frame: 24 months]
  • Effective brain connectivity [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

France · 1 center
  • CH le Vinatier — Bron

Identifiers

NCT: NCT06284382 · 2022-A02736-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗