Trauma, PsychologicalT-ODORNCT06284382
Interaction Between Early Trauma and Odor-induced Dopamine Release
A study testing High score at Childhood Trauma Questionnaire. and Low score at Childhood Trauma Questionnaire. in people with Trauma, Psychological, run by Hôpital le Vinatier at 1 site in France.
Trial summary
This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Psychological
- What is being tested?
- High score at Childhood Trauma Questionnaire. and Low score at Childhood Trauma Questionnaire.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CH le Vinatier
Bron, 69500
BRUNELIN JEROME, PhD, 33 0437915565 ext. +33, jerome.brunelin@ch-le-vinatier.fr
About this study
Official title: Consequence of Early Trauma on Odor Hedonics Appreciation and 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.
Read the 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.
- Conditions
- Trauma, Psychological
- Being tested
- High score at Childhood Trauma Questionnaire., Low score at Childhood Trauma Questionnaire.
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Presence of early trauma | Other | In the "presence of early trauma" arm, 15 participants are recruited based on a high Childhood Trauma Questionnaire total score. Receives: Other: High score at Childhood Trauma Questionnaire. |
| Absence of early trauma | Other | In the "absence of early trauma" arm, 15 participants are recruited based on a low Childhood Trauma Questionnaire total score. Receives: Other: Low score at Childhood Trauma Questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine transmission measured with positron emission tomography
Subcortical dopaminergic transmission will be analyzed, using [11C]raclopride PET activity (D2 receptor antagonist)
Measured: 24 months
Secondary outcomes (3)
Odor hedonic appreciation.
The pleasantness of the odors presented will be assessed on a scale of 1 to 9.
Measured: 24 months
Functional brain connectivity.
Resting-state functional connectivity assessed with fMRI.
Measured: 24 months
Effective brain connectivity
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start27 Apr 2026
- Primary completion27 Apr 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center, double-blind, parallel-group controlled trial with two arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JEROME BRUNELIN, Study director, PSYR2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284382
- Sponsor's protocol ID
- 2022-A02736-37
- Acronym
- T-ODOR
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequence of Early Trauma on Odor Hedonics Appreciation and DOpamine Release
- ClinicalTrials.gov ID
- NCT06284382
- Acronym / sponsor ID
- T-ODOR / 2022-A02736-37
- Conditions
- Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 27 Apr 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a prospective, single-center, double-blind, parallel-group controlled trial with two arms.
| Arm | Type | Receives |
|---|---|---|
| Presence of early trauma | Other | 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. |
| Absence of early trauma | Other | 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Presence of early trauma |
| 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. | Other | Absence of early trauma |
Primary outcome
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)
3 secondary outcomes
Odor hedonic appreciation.
Time frame: 24 months
Functional brain connectivity.
Time frame: 24 months
Effective brain connectivity
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JEROME BRUNELIN study director
PSYR2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High score at Childhood Trauma Questionnaire. and Low score at Childhood Trauma Questionnaire. in people with Trauma, Psychological, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FILIPE GALVAO (0033437915565, filipe.galvao@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine transmission measured with positron emission tomography (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.