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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02524301
Enrollment
53
Registered
2015-08-14
Start date
2009-09-30
Completion date
2016-07-29
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia, Body Dysmorphic Disorders

Keywords

anorexia nervosa, opioid receptors, Positron emission tomography (PET), diprenorphine

Brief 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.

Interventions

DRUGPositron Emission Tomography using [11C]diprenorphine

PET using \[11C\]diprenorphine

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* AN patients DSM IV criteria including amenorrhea BMI \< 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

* 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

Design outcomes

Primary

MeasureTime frameDescription
[11C]diprenorphine binding potentialweek 2Value of \[11C\]diprenorphine binding potential (BP) in predefined brains regions \[11C\] diprenorphine BP will be evaluated by brain positron emission tomography

Secondary

MeasureTime frameDescription
Correlation [11C]diprenorphine binding potentialweek 2Correlation between \[11C\]diprenorphine binding potential and plasma endogenous opioid levels

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026