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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2024
Source Centre Hospitalier Charles Perrens, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Questionnaire
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)

Locations

Country Name City State
France Centre Hospitalier Universitaire de Bordeaux Bordeaux Gironde

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & 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. — 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

Outcome

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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