NCT05315635

Brief Summary

Substance Use Disorder (SUD) and Eating Disorders (ED) are severe and persistent disturbances that are associated with significant harm. These two disorders have many clinical similarities, including craving and behavioral loss of control. Recently, craving for food has been described in newly abstinent patients with SUD. the aim of the study is to verify the hypothesis of addiction transfer based on common neurobiological mechanisms between substance craving and food craving, that postulates that food craving would correspond to an attempt to regulate substance craving (or vice versa).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

March 4, 2022

Last Update Submit

June 17, 2024

Conditions

Keywords

Substance Use DisordersEating DisordersFood cravingAddiction transferAddictionCraving

Outcome Measures

Primary Outcomes (3)

  • Craving for substance

    Measurement of craving for substances by Visual Analogue Scale (VAS) - from 0 (no desire at all) to 10 (very much in demand) / higher scores mean a worse outcome

    At the inclusion

  • Craving for substance

    Measurement of craving for substances by Visual Analogue Scale (VAS) - from 0 (no desire at all) to 10 (very much in demand) / higher scores mean a worse outcome

    At week-3

  • Craving for food

    Measurement of food craving by Food Cravings Questionnaire-Trait-Reduced (FCQ-Tr) - from NEVER to ALLWAYS / higher scores mean a worse or better outcome, depending of the question

    At the inclusion

Secondary Outcomes (11)

  • Identify common determinants of food craving in patients suffering from ED

    At inclusion

  • Identify common determinants of food craving in patients suffering from ED & SUD - Addictive characteristics :

    At inclusion

  • Identify common determinants of food craving in patients suffering from ED & SUD - Emotional characteristics

    At inclusion

  • Identify common determinants of food craving in patients suffering from ED & SUD - Psychopathological and cognitive characteristics

    At inclusion

  • Identify Medical characteristics : of food craving in patients suffering from ED - Medical characteristics :

    At inclusion

  • +6 more secondary outcomes

Study Arms (1)

Epidemiology

Inpatients who initiate treatment for a substance use disorder (SUD) will have to complete self-questionnaires, a clinical psychiatric assessment (MINI) and a cognitive assessment (MoCA). These participants will be assessed at admission in addiction unit and at discharge, 3 weeks after withdrawal. Outpatients who begin treatment for an eating disorder (ED) will have to complete self-questionnaires and a clinical psychiatric assessment (MINI) at the beginning of the outpatient treatment program

Other: Questionnaire

Interventions

Patients treated for substance use disorders and patients treated for eating disorders will have to complete self-questionnaires and a clinical psychiatric (MINI) at the inclusion. Patients suffering from substance use disorder will be assessed 3 weeks after inclusion. Questionnaires are : * Modified Yale Food Addiction (mYFAS 2.0) and Impulsive Behavior Scale (UPPS-P) * Trait Meta-Mood Scale (TMMS), Hospital Anxiety and Depression Scale (HADs), Emotional Appetite Questionnaire (EMAQ), Perceived Stress Scale (PSS-10), Multidimensional Assessment of Interoceptive Awareness (MAIA) and Five Facet Mindfulness Questionnaire (FFMQ) * Mini International Neuropsychiatric Interview (MINI), Eating Disorder Examination-Questionnaire (EDE-Q), Rosenberg's Self Esteem (RSE) and Ruminative Response Scale for Eating disorders (RRS-ED) * Pittsburgh Sleep Quality Index (PSQI) and Montreal Cognitive Assessment (MoCA)

Epidemiology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for substance use disorder/behavioral addiction (gambling) or DSM-5 diagnostic criteria for eating disorders (Anorexia nervosa, Bulimia nervosa, Hyperphagia access)

You may qualify if:

  • DSM-5 diagnostic criteria for substance use disorder/behavioral addiction (gambling) or an eating disorder (Anorexia nervosa, Bulimia nervosa or Hyperphagia access).
  • Begin treatment in addiction complex care unit, located in inter-hospital unit Charles Perrens Hospital and Bordeaux University Hospital
  • Non-opposition formulated

You may not qualify if:

  • Severely impaired physical and/or mental health that, according to the investigator, may affect the participant's compliance with the study and understanding of assessment tools
  • Trouble in understanding/writing French
  • Hospitalization for less than 3-weeks for patients with substance use disorders or behavioral addiction (gambling)
  • Be under guardianship
  • Pregnant and/or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, Gironde, 33000, France

Location

Related Publications (5)

  • Atkinson TJ. Central and peripheral neuroendocrine peptides and signalling in appetite regulation: considerations for obesity pharmacotherapy. Obes Rev. 2008 Mar;9(2):108-20. doi: 10.1111/j.1467-789X.2007.00412.x.

  • Avena NM, Murray S, Gold MS. Comparing the effects of food restriction and overeating on brain reward systems. Exp Gerontol. 2013 Oct;48(10):1062-7. doi: 10.1016/j.exger.2013.03.006. Epub 2013 Mar 25.

  • Bydlowski S, Corcos M, Jeammet P, Paterniti S, Berthoz S, Laurier C, Chambry J, Consoli SM. Emotion-processing deficits in eating disorders. Int J Eat Disord. 2005 May;37(4):321-9. doi: 10.1002/eat.20132.

  • Calero-Elvira A, Krug I, Davis K, Lopez C, Fernandez-Aranda F, Treasure J. Meta-analysis on drugs in people with eating disorders. Eur Eat Disord Rev. 2009 Jul;17(4):243-59. doi: 10.1002/erv.936.

  • Canan F, Karaca S, Sogucak S, Gecici O, Kuloglu M. Eating disorders and food addiction in men with heroin use disorder: a controlled study. Eat Weight Disord. 2017 Jun;22(2):249-257. doi: 10.1007/s40519-017-0378-9. Epub 2017 Apr 22.

MeSH Terms

Conditions

Substance-Related DisordersFeeding and Eating DisordersBehavior, Addictive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mélina FATSEAS, Prof, MD

    Physician

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

April 7, 2022

Study Start

April 1, 2022

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations