AlcoholismCRAVING-NETNCT05275166
Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography
A study testing Induction of alcohol craving and Questionnaires in people with Alcoholism and Alcohol Dependence, run by Rennes University Hospital.
Trial summary
Alcohol is the most consumed psychoactive substance in France and is responsible for 49,000 deaths per year in the country. Addictions, characterized by "the repeated impossibility of controlling a behavior and the continuation of this behavior despite the knowledge of its negative consequences", are a major public… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Alcohol Dependence
- What is being tested?
- Induction of alcohol craving and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Nov 2025
- Phase
- Interventional
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients (N=20):
- Subject with moderate to severe DSM-5 alcohol use disorder hospitalized for withdrawal as part of their routine care.
- Presence of spontaneous and/or in response to environmental stimuli (induced) self-described episodes of craving.
- Males with age ≥ 30 years and ≤ 60 years;
- Normal or corrected-to-normal visual acuity (declarative);
- Right-handed;
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- Healthy control volunteers (N=40):
- Men with age ≥ 30 years and ≤ 60 years;
- Normal or corrected-to-normal visual acuity;
- Right-handed;
- Smoker (current user, N=20) or Nonsmoker (never smoked, N=20);
- Alcohol consumption below the low-risk drinking threshold (<10 standard drinks per week)
Who cannot join
- For all subjects:
- Alcohol use in the 24 hours prior to the experiment;
- Consumption of psychoactive substances other than tobacco and alcohol (positive urine test).
- Presence of a contraindication related to the MRI technique
- Being under legal protection, and/or deprived of freedom;
- Not mastering the French language (written and oral);
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- Inability to understand the information given on the study and/or to carry out the experimental task.
- For patients:
- Presence of cognitive impairment (MoCA score < 25)
- Absence of spontaneous or induced craving episodes
- Decompensated cirrhosis: ascites and/or encephalopathy and/or jaundice and/or recent hemorrhage
- For healthy control volunteers:
- Significant medical or surgical history related to the central nervous system;
- Current use (< 30 days) of drugs affecting the central nervous system belonging to the class of antidepressants, sleeping pills and/or anxiolytics.
About this study
Alcohol is the most consumed psychoactive substance in France and is responsible for 49,000 deaths per year in the country. Addictions, characterized by "the repeated impossibility of controlling a behavior and the continuation of this behavior despite the knowledge of its negative consequences", are a major public health issue in France and worldwide. Alcohol dependence (DSM-5 moderate to severe use disorder) is a chronic behavioral disorder, whose main characteristic is its high and prolonged risk of "relapse", i.e. the resumption of problematic consumption after a period of improvement (abstinence or reduction).
One of the main components of addiction is "craving", which can be defined as the irrepressible desire to use a substance (DSM-5, American Psychiatric Association). To date, despite functional imaging studies (fMRI), the brain mechanisms involved in craving remain poorly understood. In recent years, a new neuroimaging device has become available, both in research and in clinical settings: high-resolution electroencephalography (HRE). This non-invasive method allows to observe brain activity at the millisecond level.
The objective of the CRAVING-NET project is to better understand brain function in alcohol addiction, and in particular in craving.
Read the detailed description
The objective of the CRAVING-NET project is to better understand brain function in alcohol addiction, and in particular in craving, using high-resolution electroencephalography. Brain activity following the induction of alcohol craving, as well as responses to questionnaires related to their relationship to alcohol and their state of health, which will be obtained in patients will be compared to the same responses in healthy volunteers.
- Conditions
- Alcoholism, Alcohol Dependence
- Being tested
- Induction of alcohol craving, Questionnaires
- Keywords
- alcoholism, electroencephalography, brain activity
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of alcohol cravingBehavioural
Presentation of images that may induce craving for alcohol. Recording of brain activity
QuestionnairesOther
Questionnaires related to alcohol, quality of life, anxiety and depression
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Patients hospitalized for rehab. HRE following induction of alcohol craving and questionnaires Receives: Behavioral: Induction of alcohol craving; Other: Questionnaires |
| Healthy Volunteers | Other | Healthy Volunteers with non alcohol dependance. HRE following induction of alcohol craving and questionnaires Receives: Behavioral: Induction of alcohol craving; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Source connectivity within large-scale brain networks
Difference in source connectivity within large-scale brain networks following the induction of craving episodes between alcohol-dependent patients and matched healthy participants (smokers and non-smokers). Source connectivity is measured by the strength of connections between brain regions (ratio value between 0 (no communication) and 1 (strong communication)).
Measured: 1 day
Secondary outcomes (5)
Variation in source connectivity based on AUQ
Significant difference in source connectivity between patients and volunteers based on Alcohol Urge Questionnaire (AUQ,easures craving in patients with alcohol dependence; Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect greater craving.
Measured: 1 day
Variation in source connectivity based on OCDS
Significant difference in source connectivity between patients and volunteers based on Obsessive Compulsive Drinking Scale (OCDS , allows to obtain a global alcohol appetite score and to evaluate the craving, in 14 items with a compulsion sub-score and an obsessional sub-score. Higher scores reflect greater craving.
Measured: 1 day
Variation in source connectivity based on psychological state
Significant difference in source connectivity between patients and volunteers based on Hospital Anxiety and Depression scale (HAD , allows to obtain a anxiety score and a depression score to evaluate psychological state. Two subscores, one for anxiety and one for depression. Higher sub-scores reflect higher anxiety or depression.
Measured: 1 day
Correlation between brain networks estimated by HRE and AUQ and OCDS scores
Correlation between brain networks estimated by EEG-HR and AUQ and OCDS scores at 6 months only in patients
Measured: 6 months
Correlation between EEG-HR and fMRI networks at inclusion
Correlation between EEG-HR and fMRI networks at inclusion in patients and healthy volunteers
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study startMay 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: technical resources not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Moirand, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275166
- Sponsor's protocol ID
- 35RC21_9740_CRAVING-NET
- Acronym
- CRAVING-NET
- Status last verified
- Nov 2023
- First submitted
- 2 Mar 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography
- ClinicalTrials.gov ID
- NCT05275166
- Acronym / sponsor ID
- CRAVING-NET / 35RC21_9740_CRAVING-NET
- Conditions
- Alcoholism, Alcohol Dependence
- Keywords
- alcoholism, electroencephalography, brain activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: technical resources not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Mar 2022 (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.
Alcohol is the most consumed psychoactive substance in France and is responsible for 49,000 deaths per year in the country. Addictions, characterized by "the repeated impossibility of controlling a behavior and the continuation of this behavior despite the knowledge of its negative consequences", are a major public health issue in France and worldwide. Alcohol dependence (DSM-5 moderate to severe use disorder) is a chronic behavioral disorder, whose main characteristic is its high and prolonged risk of "relapse", i.e. the resumption of problematic consumption after a period of improvement (abstinence or reduction).
One of the main components of addiction is "craving", which can be defined as the irrepressible desire to use a substance (DSM-5, American Psychiatric Association). To date, despite functional imaging studies (fMRI), the brain mechanisms involved in craving remain poorly understood. In recent years, a new neuroimaging device has become available, both in research and in clinical settings: high-resolution electroencephalography (HRE). This non-invasive method allows to observe brain activity at the millisecond level.
The objective of the CRAVING-NET project is to better understand brain function in alcohol addiction, and in particular in craving.
Detailed description
The objective of the CRAVING-NET project is to better understand brain function in alcohol addiction, and in particular in craving, using high-resolution electroencephalography. Brain activity following the induction of alcohol craving, as well as responses to questionnaires related to their relationship to alcohol and their state of health, which will be obtained in patients will be compared to the same responses in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Behavioral: Induction of alcohol craving, Other: QuestionnairesPatients hospitalized for rehab. HRE following induction of alcohol craving and questionnaires |
| Healthy Volunteers | Other | Behavioral: Induction of alcohol craving, Other: QuestionnairesHealthy Volunteers with non alcohol dependance. HRE following induction of alcohol craving and questionnaires |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject with moderate to severe DSM-5 alcohol use disorder hospitalized for withdrawal as part of their routine care.
- Presence of spontaneous and/or in response to environmental stimuli (induced) self-described episodes of craving.
- Males with age ≥ 30 years and ≤ 60 years;
- Normal or corrected-to-normal visual acuity (declarative);
- Right-handed;
Key exclusion criteria (14 listed)
- Alcohol use in the 24 hours prior to the experiment;
- Consumption of psychoactive substances other than tobacco and alcohol (positive urine test).
- Presence of a contraindication related to the MRI technique
- Being under legal protection, and/or deprived of freedom;
- Not mastering the French language (written and oral);
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 |
|---|---|---|
| Induction of alcohol cravingPresentation of images that may induce craving for alcohol. Recording of brain activity | Behavioural | Healthy Volunteers, Patients |
| QuestionnairesQuestionnaires related to alcohol, quality of life, anxiety and depression | Other | Healthy Volunteers, Patients |
Primary outcome
Source connectivity within large-scale brain networks
Time frame: 1 day
Difference in source connectivity within large-scale brain networks following the induction of craving episodes between alcohol-dependent patients and matched healthy participants (smokers and non-smokers). Source connectivity is measured by the strength of connections between brain regions (ratio value between 0 (no communication) and 1 (strong communication)).
5 secondary outcomes
Variation in source connectivity based on AUQ
Time frame: 1 day
Variation in source connectivity based on OCDS
Time frame: 1 day
Variation in source connectivity based on psychological state
Time frame: 1 day
Correlation between brain networks estimated by HRE and AUQ and OCDS scores
Time frame: 6 months
Correlation between EEG-HR and fMRI networks at inclusion
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Romain Moirand, Pr principal investigator
Rennes University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Induction of alcohol craving and Questionnaires in people with Alcoholism and Alcohol Dependence, run by Rennes University Hospital.
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 12 inclusion and 14 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: withdrawn, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Source connectivity within large-scale brain networks (time frame: 1 day). 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 4 Dec 2023.