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Not yet recruiting

NCT Number: NCT07830680

Physiopathology of Behavioral Addictions and Biomarkers

The goal of this observational study is to evaluate the expression of miR-10a-5p in the blood in patients with sexual addiction or food addiction. The main question it aims to answer is : To determine whether adults patients with SA or FA exhibit a distinct blood miR-10a-5p expression profile compared with matched healthy controls.

For all participants, one blood sample will be collected.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For patients with FA:

  • Male and females ≥ 18 years old
  • Already in care or newly initiating care
  • Participating to EVALADD cohort
  • Current diagnosis of FA
  • Oral consent provided
  • Affiliated with French social security system or beneficiary from such system

For healthy controls matched to patients with FA:

  • Male and females ≥ 18 years old
  • Oral consent provided
  • Affiliated with French social security system or beneficiary from such system

For patients with SA:

  • Male ≥ 18 years old
  • Already in care or newly initiating care
  • Participating to EVALADD cohort
  • Current diagnosis of SA
  • Oral consent provided
  • Affiliated with French social security system or beneficiary from such system

For healthy controls matched to patients with SA:

  • Male ≥ 18 years old
  • Oral consent provided
  • Affiliated with French social security system or beneficiary from such system

Exclusion criteria

For patients with FA:

  • Presence of a current diagnosis of SA
  • Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
  • Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
  • Pregnancy or breastfeeding woman
  • Trusteeship or curatorship
  • Major cognitive impairment
  • Not fluent in French

For patients with SA:

  • Presence of a current diagnosis of FA
  • Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
  • Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
  • Trusteeship or curatorship
  • Major cognitive impairment
  • Not fluent in French

For healthy controls:

  • Without a current diagnosis of FA
  • Without a current diagnosis of SA
  • Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
  • Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
  • Pregnancy or breastfeeding woman
  • Trusteeship or curatorship
  • Major cognitive impairment
  • Not fluent in French

Treatment and study plan

Blood sampling

Biological

One blood sample wiil be collected into a 10mL K2EDTA BD Vacutainer® tube

Primary outcomes

  1. Blood miR-10a-5p expression

    Time frame: 3 months

    Quantitative comparison of blood miR-10a-5p expression levels between patients with SA or FA and matched healthy controls.

Secondary outcomes

  1. Blood additional circulating miRs expression

    Time frame: 3 months

    Quantitative comparison of blood expression levels of preselected candidate miRs between patients with SA or FA and matched healthy controls.

  2. Clinical Characteristics

    Time frame: 3 months

    Association between blood expression levels of circulating miRs and clinical characteristics

Study contacts

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

Pr Caroline Victorri-Vigneau

CONTACT

[email protected]

02.40.84.76.20

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • INSERM U1216 Grenoble Institut des Neurosciences

Registry information

Official study title

Physiopathology of Behavioral Addictions and Biomarkers: microRNAs Implication - MiRACle : a Pilot Study.

Acronym: MiRACle

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 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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