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CompletedNCT02524301Updated Oct 29, 2018

Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

An interventional study of Positron Emission Tomography using [11C]diprenorphine in Body Dysmorphic Disorders and Anorexia, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 3 sites in France. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-29.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 years 11 months after the study started (first participant enrolled Sep 2009, registered Aug 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.

02

Conditions studied

  • Body Dysmorphic Disorders
  • Anorexia

Keywords

  • anorexia nervosa
  • opioid receptors
  • Positron emission tomography (PET)
  • diprenorphine
03

In context

Body Dysmorphic Disorders

56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.

This study's enrollment of 53 is close to the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.

Browse Body Dysmorphic Disorders studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • AN patients DSM IV criteria including amenorrhea \< 17.5 kg/m² and abnormal nutritional markers Group 1 (N=15) : long period of / recurrent weight loss (> 2 yrs) Group 2 (N=15) : recent weight loss (6 to 12 months)
  • Recovered AN patients History of AN Weight recovery and BMI > 18.5 kg/m², stable for at least 12 months Normal nutritional markers Group 1 (N=15) : menses recovery after bodyweight stabilization Group 2 (N=15) : long persistence of amenorrhea (> 12 months) despite weight recovery
  • Healthy volunteers (N=15) BMI between 18.5 and 25 kg/m², normal nutritional markers, absence of psychiatric or organic pathology
  • For all subjects Women 18-35 yrs Written and sign consent Affiliation to health insurance

Exclusion criteria

Exclusion Criteria:

  • History of heart failure
  • Psychotropic treatment , antiepileptics
  • Ongoing or suspected pregnancy, positive beta HCG test before brain imaging
  • Intense physical activity
  • Constrains for MRI (ferromagnetic implants or claustrophobia)
  • Refusal to be informed in case of incidentaloma revealed by brain imaging
  • Refusal for written consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    anorexia nervosa patients

    Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

    Drug: Positron Emission Tomography using [11C]diprenorphine

  • Experimental
    Recovered anorexia nervosa patients

    Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

    Drug: Positron Emission Tomography using [11C]diprenorphine

  • Experimental
    Healthy Volonteers

    Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

    Drug: Positron Emission Tomography using [11C]diprenorphine

Interventions

  • DrugPositron Emission Tomography using [11C]diprenorphine

    PET using \[11C\]diprenorphine

    Also known as: PET

06

What researchers measure

Primary outcomes

  1. [11C]diprenorphine binding potential

    Value of \[11C\]diprenorphine binding potential (BP) in predefined brains regions \[11C\] diprenorphine BP will be evaluated by brain positron emission tomography

    Time frame: week 2

Secondary outcomes

  1. Correlation [11C]diprenorphine binding potential

    Correlation between \[11C\]diprenorphine binding potential and plasma endogenous opioid levels

    Time frame: week 2

  2. Correlation [11C]diprenorphine binding potential

    Correlation between \[11C\]diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement

    Time frame: week 2

  3. Correlation [11C]diprenorphine binding potential

    Correlation between \[11C\]diprenorphine binding potential and appetite regulating hormones

    Time frame: week 2

  4. Correlation [11C]diprenorphine binding potential

    Correlation between \[11C\]diprenorphine binding potential and LH response during GnRH test

    Time frame: week 2

07

Study locations

3 sites
  • CHU Clermont Ferrand
    Clermont-Ferrand, France
  • CNRH
    Clermont-Ferrand, France
  • CHU Saint-Etienne
    Saint-Etienne, 42055, France
08

References and documents

Publications

  • Galusca B, Traverse B, Costes N, Massoubre C, Le Bars D, Estour B, Germain N, Redoute J. Decreased cerebral opioid receptors availability related to hormonal and psychometric profile in restrictive-type anorexia nervosa. Psychoneuroendocrinology. 2020 Aug;118:104711. doi: 10.1016/j.psyneuen.2020.104711. Epub 2020 May 19. PubMed 32460196 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02524301
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Aug 14, 2015
Start date
Sep 2009
Primary completion
Jul 28, 2016
Completion
Jul 29, 2016
Last update
Oct 29, 2018

Study contacts

Bruno Estour, PhD
principal investigator · CHU Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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