Interaction Between Early Trauma and Odor-induced Dopamine Release

NCT06284382 | Not Yet Recruiting

• 1 other identifier: 2022-A02736-37
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trauma, Psychological

Outcome Measures

Primary Outcomes (1)

• Dopamine transmission measured with positron emission tomography

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

  24 months

Secondary Outcomes (3)

• Odor hedonic appreciation.

  24 months

• Functional brain connectivity.

  24 months

• Effective brain connectivity

  24 months

Study Arms (2)

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.

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.

Other: Low score at Childhood Trauma Questionnaire.

Interventions

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.

Presence of early trauma

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.

Absence of early trauma

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• JEROME BRUNELIN

  PSYR2

  STUDY DIRECTOR

Central Study Contacts

FILIPE GALVAO

CONTACT

0033437915565; filipe.galvao@ch-le-vinatier.fr

VERONIQUE VIAL

CONTACT

0033437915522; veronique.vial@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, double-blind, parallel-group controlled trial with two arms.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 28, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share