ObesityADOBNCT04613791
Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital
An observational study of Obesity, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Blood test
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2021to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The target population for this study corresponds to all patients being managed for obesity (Body Mass Index ≥ 30 kg.m-²). The source population for this study corresponds to all patients being managed by the obesity clinic at Nîmes University Hospital for obesity with a BMI ≥ 30 kg.m-² at the time of their first visit (complete hospitalization outpatients or consultation) for initiation to management (incident subjects).
Who may be able to join
None listed.
Who cannot join
- Patient with psychiatric disorder reducing capacity for comprehension.
- Patient in an exclusion period determined by another study.
- Patient under legal guardianship, tutorship or curatorship.
- Patient to whom it is impossible to give clear information
- Patient who is pregnant, about to give birth or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nimes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Emma LUCQUIAUD, Dr.
About this study
Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. One of the external factors that can intervene in the genesis of obesity is the existence of eating disorders: bulimic hyperphagia. Some teams consider bulimic hyperphagia as a form of addiction. After bariatric surgery, the appearance of new addictions has been observed.
In connection with Pr Perney's addictology department, the investigators have observed that some patients under treatment for obesity at the endocrinology department subsequently developed other addictions, in particular misuse of alcohol.
Read more
The hypotheses of this research are :
There appears to be a transfer from eating disorders to substance misuse addiction in post-treatment of obesity, particularly in patients who have undergone bariatric surgery.
The misuse of addictive substances most concerned by this transfer of addiction in the post-treatment of obesity, particularly after bariatric surgery, seems to be the misuse of alcohol.
This will be the first French cohort study on addictive behaviors in patients undergoing bariatric surgery and the first international study including non-operated obese patients benefiting from medical care alone. This study will improve the multidisciplinary management of these patients by integrating addictologists.
- Conditions
- Obesity
- Being tested
- Blood test
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
Also called Distribution of the following questionnaires: AUDIT, CAST, HADS, BES, Fagerstrom test and the EQVOD scale
Collection of epidemio-clinical, biological, radiological and therapeutic patient data. Study samples collected from 154 patients to determine whether a particular immune profile could identify individuals prone to insulin resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.
Measured: Day 0
Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends).Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.
Measured: Month 12
Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points.This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.
Measured: Month 24
Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.
Measured: Day 0
Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.
Measured: Month 12
Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.
Measured: Month 24
Secondary outcomes (33)
Smoking (tobacco addiction) according to the Fagerström test
The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.
Measured: Day 0
Smoking (tobacco addiction) according to the Fagerström test
The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.
Measured: Month 12
Smoking (tobacco addiction) according to the Fagerström test
The Fagerström test consists of six questions. A score of 0 - 10 is obtained depending on the answers given. A score of 0 - 2 = zero addiction, 3 - 4 = slight addiction, 5 - 6 = moderate addiction, 7 ou 8 heavy addiction and 9 - 10 = very heavy addiction.
Measured: Month 24
Cannabis addiction
The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.
Measured: Day 0
Cannabis addiction
The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.
Measured: Month 12
Cannabis addiction
The Cannabis Abuse Screening Test (CAST) questionnaire has 6 questions to which the answer YES (=1) or NO (=0) is given. A score ≥ 3 on the CAST indicates addiction to Cannabis.
Measured: Month 24
Use of cocaine
The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No
Measured: Day 0
Use of cocaine
The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No
Measured: Month 12
Use of cocaine
The patient will be interviewed to find out whether he/she uses cocaine. This will be noted as Yes/No
Measured: Month 24
Use of amphetamines
The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No
Measured: Day 0
Use of amphetamines
The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No
Measured: Month 12
Use of amphetamines
The patient will be interviewed to find out whether he/she uses amphetamines. This will be noted as Yes/No
Measured: Month 24
Use of opioids
The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No
Measured: Day 0
Use of opioids
The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No
Measured: Month 12
Use of opioids
The patient will be interviewed to find out whether he/she uses opioids. This will be noted as Yes/No
Measured: Month 24
Use of hallucinogenic drugs and/or new synthetic drugs
The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No
Measured: Day 0
Use of hallucinogenic drugs and/or new synthetic drugs
The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No
Measured: Month 12
Use of hallucinogenic drugs and/or new synthetic drugs
The patient will be interviewed to find out whether he/she uses hallucinogenic drugs and/or new synthetic drugs. This will be noted as Yes/No
Measured: Month 24
Eating disorders
A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.
Measured: Day 0
Eating disorders
A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.
Measured: Month 12
Eating disorders
A score ≥ 17 on the BES (Binge Eating Scale) questionnaire indicates presence of an eating disorder.
Measured: Month 24
Comorbidities
Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.
Measured: Day 0
Comorbidities
Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.
Measured: Month 12
Comorbidities
Presence of comorbidities for obesity (High blood pressure / Glucose intolerance or Diabetes / Sleep apnea syndrome / Dyslipidemia / Hepatic Steatosis / Cardiovascular diseases) will be noted from data in the patient file.
Measured: Month 24
Quality of Life according to the EQVOD scale
The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.
Measured: Day 0
Quality of Life according to the EQVOD scale
The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.
Measured: Month 12
Quality of Life according to the EQVOD scale
The "Echelle de Qualité de Vie, Obésité et Diététique - EQVOD" (Quality of Life, Obesity and Dietetics Scale ) is a self-questionnaire validated in French which is adapted to the socio-cultural factors of obesity in France, making it possible to take into account the effects of dietary treatments on the quality of life of obese subjects (see Appendix 17.5) (Ziegler et al. 2005). It consists of 36 items, rated from 1 (always/highly) to 5 (never/not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sexual life - Q23-Q26, food well-being - Q27-Q31 and diet experience - Q32-Q36). The rating for each dimension is reported as 100. The closer the score is to 100, the better the quality of life related to that dimension.
Measured: Month 24
Anxiety and Depression
The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong \& Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.
The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.
Measured: Day 0
Anxiety and Depression
The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong \& Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.
The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.
Measured: Month 12
Anxiety and Depression
The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that assesses depressive and anxiety symptomatology (excluding somatic symptoms) and measures severity in patients between 16 and 65 years of age from a hospital environment (Zigmong \& Snaith 1983, Snaith et al. 2003). The HADS consists of two parts: (a) 7 questions for screening for depression, and (b) 7 questions for screening for anxiety disorders. Each question receives a score between 0 and 3. The score for each part is obtained by adding the items that make up the part. The higher the score, the greater the severity of the corresponding symptoms.
The French version was validated by Razavi et al. 1989 and Friedman et al. 2001.
Measured: Month 24
Binge eating
The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).
Measured: Day 0
Binge eating
The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).
Measured: Month 12
Binge eating
The Binge Eating Scale (BES) is a self-administered questionnaire that diagnoses Binge Eating Disorder (BED) and assesses the behavioural, emotional and cognitive symptoms associated with Binge Eating Disorder in obese individuals (Gormally et al. 1982). It is composed of 16 items corresponding to groups of sentences including one to be selected from 3 to 4 propositions, which best describe how one feels. For each item, the subject has to choose the formulation that best corresponds to his current situation, which results in a score varying between 0 and 3 or between 0 and 2 for each item. Half of the items measure eating behaviours and the other half assess feelings or cognitions occurring during compulsive episodes. It gives a total score (from 0 to 46) that reflects the severity of the BED. A score greater than or equal to 18 indicates significant bulimic hyperphagia. The French version of this questionnaire was translated and validated by Brunault et al (2016).
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start16 Feb 2021
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613791
- Sponsor's protocol ID
- NIMAO/2019-2/FB-01
- Acronym
- ADOB
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital
- ClinicalTrials.gov ID
- NCT04613791
- Acronym / sponsor ID
- ADOB / NIMAO/2019-2/FB-01
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. One of the external factors that can intervene in the genesis of obesity is the existence of eating disorders: bulimic hyperphagia. Some teams consider bulimic hyperphagia as a form of addiction. After bariatric surgery, the appearance of new addictions has been observed.
In connection with Pr Perney's addictology department, the investigators have observed that some patients under treatment for obesity at the endocrinology department subsequently developed other addictions, in particular misuse of alcohol.
The hypotheses of this research are :
There appears to be a transfer from eating disorders to substance misuse addiction in post-treatment of obesity, particularly in patients who have undergone bariatric surgery.
The misuse of addictive substances most concerned by this transfer of addiction in the post-treatment of obesity, particularly after bariatric surgery, seems to be the misuse of alcohol.
This will be the first French cohort study on addictive behaviors in patients undergoing bariatric surgery and the first international study including non-operated obese patients benefiting from medical care alone. This study will improve the multidisciplinary management of these patients by integrating addictologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study corresponds to all patients being managed for obesity (Body Mass Index ≥ 30 kg.m-²). The source population for this study corresponds to all patients being managed by the obesity clinic at Nîmes University Hospital for obesity with a BMI ≥ 30 kg.m-² at the time of their first visit (complete hospitalization outpatients or consultation) for initiation to management (incident subjects).
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patient with psychiatric disorder reducing capacity for comprehension.
- Patient in an exclusion period determined by another study.
- Patient under legal guardianship, tutorship or curatorship.
- Patient to whom it is impossible to give clear information
- Patient who is pregnant, about to give birth or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAlso: Distribution of the following questionnaires: AUDIT, CAST, HADS, BES, Fagerstrom test and the EQVOD scaleCollection of epidemio-clinical, biological, radiological and therapeutic patient data. Study samples collected from 154 patients to determine whether a particular immune profile could identify individuals prone to insulin resistance | Biological | – |
Primary outcome
Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
Time frame: Day 0
The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.
Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
Time frame: Month 12
The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends).Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points. This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.
Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire.
Time frame: Month 24
The Alcohol Use Disorders Identification Test (AUDIT) self-questionnaire consists of 10 questions covering consumption (the first 3 questions), behaviors that may evoke dependency (not being able to stop drinking, inability to carry out one's plans, needing a drink in the morning) and problems related to alcohol consumption (guilt or remorse, memory loss, injuries, concerns from family and friends). Each question can be scored from 0 (low) - 4 (high) points, leading to a possible total score of 40 points.This questionnaire therefore makes it possible to cover all aspects of alcohol misuse in a very short space of time. It has been validated with good diagnostic performance: sensitivity at 92% and specificity at 94% for a threshold ≥ 8 (Saunders et al. 1993; Coulton et al. 2006). Moreover, this questionnaire is very widely used and recognized in scientific articles on addictology.
Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
Time frame: Day 0
The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.
Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
Time frame: Month 12
The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.
Presence of alcohol abuse evaluated at the first clinical consultation according to the DSM-5 questionnaire
Time frame: Month 24
The DSM-5 criteria are used to identify depression in all patients with high alcohol consumption (over14 glasses a week for women, 21 for men, or more than 4 glasses on one occasion). The DSM-5 outlines the following criterion to make a diagnosis of depression. The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.
33 secondary outcomes
Smoking (tobacco addiction) according to the Fagerström test
Time frame: Day 0
Smoking (tobacco addiction) according to the Fagerström test
Time frame: Month 12
Smoking (tobacco addiction) according to the Fagerström test
Time frame: Month 24
Cannabis addiction
Time frame: Day 0
Cannabis addiction
Time frame: Month 12
Cannabis addiction
Time frame: Month 24
Use of cocaine
Time frame: Day 0
Use of cocaine
Time frame: Month 12
Use of cocaine
Time frame: Month 24
Use of amphetamines
Time frame: Day 0
Use of amphetamines
Time frame: Month 12
Use of amphetamines
Time frame: Month 24
Use of opioids
Time frame: Day 0
Use of opioids
Time frame: Month 12
Use of opioids
Time frame: Month 24
Use of hallucinogenic drugs and/or new synthetic drugs
Time frame: Day 0
Use of hallucinogenic drugs and/or new synthetic drugs
Time frame: Month 12
Use of hallucinogenic drugs and/or new synthetic drugs
Time frame: Month 24
Eating disorders
Time frame: Day 0
Eating disorders
Time frame: Month 12
Eating disorders
Time frame: Month 24
Comorbidities
Time frame: Day 0
Comorbidities
Time frame: Month 12
Comorbidities
Time frame: Month 24
Quality of Life according to the EQVOD scale
Time frame: Day 0
Quality of Life according to the EQVOD scale
Time frame: Month 12
Quality of Life according to the EQVOD scale
Time frame: Month 24
Anxiety and Depression
Time frame: Day 0
Anxiety and Depression
Time frame: Month 12
Anxiety and Depression
Time frame: Month 24
Binge eating
Time frame: Day 0
Binge eating
Time frame: Month 12
Binge eating
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Centre Hospitalier Universitaire de Nīmes 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 0 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma LUCQUIAUD, Dr. (+33 4.66.68.33.21, emma.lucquiaud@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of alcohol abuse evaluated at the first clinical consultation according to the AUDIT(Alcohol Use Disorders Identification Test) questionnaire. (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.