- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315635
Substance Use and Eating Disorders : Food Craving and Addiction Transfer (SUED)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gironde
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Bordeaux, Gironde, France, 33000
- Centre Hospitalier Universitaire de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Individuals participating in another study that includes an ongoing exclusion period.
- Be under guardianship
- Pregnant and/or lactating woman
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 |
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 :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Craving for substance
Time Frame: At the inclusion
|
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
Time Frame: At week-3
|
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
Time Frame: At the inclusion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify common determinants of food craving in patients suffering from ED
Time Frame: At inclusion
|
Questionnaires for Addictive characteristics : Modified Yale Food Addiction
|
At inclusion
|
|
Identify common determinants of food craving in patients suffering from ED & SUD - Addictive characteristics :
Time Frame: At inclusion
|
Impulsive Behavior Scale 4-point Likert scale: 1 (Agree Strongly), 2 (Agree Some), 3 (Disagree Some), and 4 (Disagree Strongly)
|
At inclusion
|
|
Identify common determinants of food craving in patients suffering from ED & SUD - Emotional characteristics
Time Frame: At inclusion
|
Trait Meta-Mood Scale from NOT AT ALL AGREE to TOTALLY AGREE / higher scores mean a worse or better outcome, depending of the question
|
At inclusion
|
|
Identify common determinants of food craving in patients suffering from ED & SUD - Psychopathological and cognitive characteristics
Time Frame: At inclusion
|
Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question
|
At inclusion
|
|
Identify Medical characteristics : of food craving in patients suffering from ED - Medical characteristics :
Time Frame: At inclusion
|
BMI in kg/m²
|
At inclusion
|
|
Identify Medical characteristics : of food craving in patients suffering from SUD
Time Frame: At inclusion and at week-3
|
BMI in kg/m²
|
At inclusion and at week-3
|
|
Identify cognitive characteristics of food craving in patients suffering from ED
Time Frame: At inclusion
|
Pittsburgh Sleep Quality Index (21 self-rated items are combined to form seven "component scores", each of which has a range of 0-3 points.
In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty.
The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.)
Montreal Cognitive Assessment (30-question test - score of 25 and under is considered at-risk of dementia)
|
At inclusion
|
|
Identify cognitive characteristics of food craving in patients suffering from SUD
Time Frame: At inclusion and at week-3
|
Pittsburgh Sleep Quality Index (21 self-rated items are combined to form seven "component scores", each of which has a range of 0-3 points.
In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty.
The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.)
Montreal Cognitive Assessment (30-question test - score of 25 and under is considered at-risk of dementia)
|
At inclusion and at week-3
|
|
Identify addictive characteristics of substances craving in patients suffering from SUD
Time Frame: At week-3 At inclusion and at week-3
|
Impulsive Behavior Scale 4-point Likert scale: 1 (Agree Strongly), 2 (Agree Some), 3 (Disagree Some), and 4 (Disagree Strongly)
|
At week-3 At inclusion and at week-3
|
|
Identify emotional characteristics of substances craving in patients suffering from SUD
Time Frame: At week-3
|
Trait Meta-Mood Scale, from NOT AT ALL AGREE to TOTALLY AGREE / higher scores mean a worse or better outcome, depending of the question
|
At week-3
|
|
Identify psychopathological characteristics of substances craving in patients suffering from SUD
Time Frame: At week-3
|
Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question
|
At week-3
|
Collaborators and Investigators
Investigators
- Study Director: Mélina FATSEAS, Prof, MD, Physician
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A00126-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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