Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 8:59 PM
Study NCT ID:
NCT05315635
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Substance Use and Eating Disorders : Food Craving and Addiction Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Craving for substance', 'timeFrame': 'At the inclusion', 'description': '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'}, {'measure': 'Craving for substance', 'timeFrame': 'At week-3', 'description': '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'}, {'measure': 'Craving for food', 'timeFrame': 'At the inclusion', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Identify common determinants of food craving in patients suffering from ED', 'timeFrame': 'At inclusion', 'description': 'Questionnaires for Addictive characteristics : Modified Yale Food Addiction'}, {'measure': 'Identify common determinants of food craving in patients suffering from ED & SUD - Addictive characteristics :', 'timeFrame': 'At inclusion', 'description': 'Impulsive Behavior Scale 4-point Likert scale: 1 (Agree Strongly), 2 (Agree Some), 3 (Disagree Some), and 4 (Disagree Strongly)'}, {'measure': 'Identify common determinants of food craving in patients suffering from ED & SUD - Emotional characteristics', 'timeFrame': 'At inclusion', 'description': 'Trait Meta-Mood Scale from NOT AT ALL AGREE to TOTALLY AGREE / higher scores mean a worse or better outcome, depending of the question'}, {'measure': 'Identify common determinants of food craving in patients suffering from ED & SUD - Psychopathological and cognitive characteristics', 'timeFrame': 'At inclusion', 'description': 'Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question'}, {'measure': 'Identify Medical characteristics : of food craving in patients suffering from ED - Medical characteristics :', 'timeFrame': 'At inclusion', 'description': 'BMI in kg/m²'}, {'measure': 'Identify Medical characteristics : of food craving in patients suffering from SUD', 'timeFrame': 'At inclusion and at week-3', 'description': 'BMI in kg/m²'}, {'measure': 'Identify cognitive characteristics of food craving in patients suffering from ED', 'timeFrame': 'At inclusion', 'description': '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)'}, {'measure': 'Identify cognitive characteristics of food craving in patients suffering from SUD', 'timeFrame': 'At inclusion and at week-3', 'description': '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)'}, {'measure': 'Identify addictive characteristics of substances craving in patients suffering from SUD', 'timeFrame': 'At week-3 At inclusion and at week-3', 'description': 'Impulsive Behavior Scale 4-point Likert scale: 1 (Agree Strongly), 2 (Agree Some), 3 (Disagree Some), and 4 (Disagree Strongly)'}, {'measure': 'Identify emotional characteristics of substances craving in patients suffering from SUD', 'timeFrame': 'At week-3', 'description': 'Trait Meta-Mood Scale, from NOT AT ALL AGREE to TOTALLY AGREE / higher scores mean a worse or better outcome, depending of the question'}, {'measure': 'Identify psychopathological characteristics of substances craving in patients suffering from SUD', 'timeFrame': 'At week-3', 'description': 'Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Substance Use Disorders', 'Eating Disorders', 'Food craving', 'Addiction transfer', 'Addiction', 'Craving'], 'conditions': ['Substance Use Disorders', 'Eating Disorders']}, 'referencesModule': {'references': [{'pmid': '18257752', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23535488', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '15856501', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '19475697', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28434177', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'The knowledge of existence of common addictive, neurobiological and clinical processes between substance use disorders and eating disorders has been a promising approach for a better understanding of the factors involved in the emergence and maintenance of these disorders. Several studies have shown that increased palatable food with high sugar or fat content causes brain neurochemistry changes similar to those observed after use of addictive drugs. Clinical and behavioral similarities concerning craving, loss of control and use as a coping strategy have also been highlighted. Craving is considered as a clinical marker of addiction and a potent predictor of relapse vulnerability. In substance addiction, the link between craving, use and relapse has been previously demonstrated in experimental and daily life studies. The main objective of this study is to examine the hypothesis of addiction transfer between Substance Use Disorders and Eating Disorders, according to which food craving for palatable foods would correspond to an attempt to regulate substance craving or vice versa. One assumption is that food intake could be used to alleviate craving for substances in patients hospitalized for substance use disorder. The secondary objective is to explore psychopathological, addictive, and medical similarities between substance use disorder and eating disorder participants. Included patients (group 1: substance use disorder participants and group 2: eating disorder) will be asked to answer different self-questionnaires, as well as a clinical psychiatric (MINI) and cognitive (MoCA) assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* DSM-5 diagnostic criteria for substance use disorder/behavioral addiction (gambling) or an eating disorder (Anorexia nervosa, Bulimia nervosa or Hyperphagia access).\n* Begin treatment in addiction complex care unit, located in inter-hospital unit Charles Perrens Hospital and Bordeaux University Hospital\n* Non-opposition formulated\n\nExclusion Criteria:\n\n* 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\n* Trouble in understanding/writing French\n* Hospitalization for less than 3-weeks for patients with substance use disorders or behavioral addiction (gambling)\n* Individuals participating in another study that includes an ongoing exclusion period.\n* Be under guardianship\n* Pregnant and/or lactating woman"}, 'identificationModule': {'nctId': 'NCT05315635', 'acronym': 'SUED', 'briefTitle': 'Substance Use and Eating Disorders : Food Craving and Addiction Transfer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centre Hospitalier Charles Perrens, Bordeaux'}, 'officialTitle': 'Substance Use and Eating Disorders : Food Craving and Addiction Transfer', 'orgStudyIdInfo': {'id': '2022-A00126-37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidemiology', 'description': '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).\n\nThese participants will be assessed at admission in addiction unit and at discharge, 3 weeks after withdrawal.\n\nOutpatients 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', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': "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.\n\nPatients suffering from substance use disorder will be assessed 3 weeks after inclusion.\n\nQuestionnaires are :\n\n* Modified Yale Food Addiction (mYFAS 2.0) and Impulsive Behavior Scale (UPPS-P)\n* 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)\n* 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)\n* Pittsburgh Sleep Quality Index (PSQI) and Montreal Cognitive Assessment (MoCA)", 'armGroupLabels': ['Epidemiology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Mélina FATSEAS, Prof, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Charles Perrens, Bordeaux', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}