Substance Use Disorders Clinical Trial
— SUEDOfficial title:
Substance Use and Eating Disorders : Food Craving and Addiction Transfer
NCT number | NCT05315635 |
Other study ID # | 2022-A00126-37 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | April 1, 2024 |
Verified date | June 2024 |
Source | Centre Hospitalier Charles Perrens, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 294 |
Est. completion date | April 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Bordeaux | Bordeaux | Gironde |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Charles Perrens, Bordeaux |
France,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Identify common determinants of food craving in patients suffering from ED | Questionnaires for Addictive characteristics : Modified Yale Food Addiction | At inclusion | |
Secondary | Identify common determinants of food craving in patients suffering from ED & SUD - Addictive characteristics : | Impulsive Behavior Scale 4-point Likert scale: 1 (Agree Strongly), 2 (Agree Some), 3 (Disagree Some), and 4 (Disagree Strongly) | At inclusion | |
Secondary | Identify common determinants of food craving in patients suffering from ED & SUD - Emotional characteristics | 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 | |
Secondary | Identify common determinants of food craving in patients suffering from ED & SUD - Psychopathological and cognitive characteristics | Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question | At inclusion | |
Secondary | Identify Medical characteristics : of food craving in patients suffering from ED - Medical characteristics : | BMI in kg/m² | At inclusion | |
Secondary | Identify Medical characteristics : of food craving in patients suffering from SUD | BMI in kg/m² | At inclusion and at week-3 | |
Secondary | Identify cognitive characteristics of food craving in patients suffering from ED | 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 | |
Secondary | Identify cognitive characteristics of food craving in patients suffering from SUD | 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 | |
Secondary | Identify addictive characteristics of substances craving in patients suffering from SUD | 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 | |
Secondary | Identify emotional characteristics of substances craving in patients suffering from SUD | 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 | |
Secondary | Identify psychopathological characteristics of substances craving in patients suffering from SUD | Eating Disorder Examination-Questionnaire, from NEVER to EVERY DAY / higher scores mean a worse or better outcome, depending of the question | At week-3 |
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