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Substance Use DisordersSUEDNCT05315635

Substance Use and Eating Disorders : Food Craving and Addiction Transfer

An observational study of Substance Use Disorders and Eating Disorders, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance Use Disorders, Eating Disorders
What is being tested?
Questionnaire
How many people
294 participants
Where
1 siteFrance
Study dates
1 Apr 2022to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, Gironde, 33000

Other trials in France

About this study

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).

Read the detailed 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.

Being tested
Questionnaire
Keywords
Substance Use Disorders, Eating Disorders, Food craving, Addiction transfer, Addiction, Craving
Medical subject headings
Substance-Related Disorders, Feeding and Eating Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    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)
Study groups in NCT05315635
Study groupRoleWhat they receive
EpidemiologyInpatients 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
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At the inclusion

  2. 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

    Measured: At week-3

  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

    Measured: At the inclusion

Secondary outcomes (11)

  1. Identify common determinants of food craving in patients suffering from ED

    Questionnaires for Addictive characteristics : Modified Yale Food Addiction

    Measured: At inclusion

  2. 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)

    Measured: At inclusion

  3. 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

    Measured: At inclusion

  4. 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

    Measured: At inclusion

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

    BMI in kg/m²

    Measured: At inclusion

  6. Identify Medical characteristics : of food craving in patients suffering from SUD

    BMI in kg/m²

    Measured: At inclusion and at week-3

  7. 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)

    Measured: At inclusion

  8. 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)

    Measured: At inclusion and at week-3

  9. 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)

    Measured: At week-3 At inclusion and at week-3

  10. 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

    Measured: At week-3

  11. 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

    Measured: At week-3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Mar 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05315635
Sponsor's protocol ID
2022-A00126-37
Acronym
SUED
Status last verified
Jun 2024
First submitted
4 Mar 2022
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18257752

  • 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.

    PubMed 23535488

  • 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.

    PubMed 15856501

  • 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.

    PubMed 19475697

  • 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.

    PubMed 28434177

  • Pavirani L, Seelarbokus BA, Marinelli L, Desnavailles P, Berthoz S, Fatseas M. Associations Between Vitamin D Status and Clinical Presentation Among French Inpatients With Substance Use Disorders. Addict Biol. 2026 Jan;31(1):e70110. doi: 10.1111/adb.70110.

    PubMed 41502297

Questions about this trial

What is this clinical trial studying?

An observational study of Substance Use Disorders and Eating Disorders, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Craving for substance (time frame: At the inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05315635, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

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SUED Clinical Trial NCT05315635 | AzTrials