Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography (CRAVING-NET)
Primary Purpose
Alcoholism, Alcohol Dependence
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Induction of alcohol craving
Questionnaires
Sponsored by
About this trial
This is an interventional basic science trial for Alcoholism focused on measuring alcoholism, electroencephalography, brain activity
Eligibility Criteria
Inclusion Criteria:
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;
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)
Exclusion Criteria:
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);
- 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.
Sites / Locations
- CHU Rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients
Healthy Volunteers
Arm Description
Patients hospitalized for rehab. HRE following induction of alcohol craving and questionnaires
Healthy Volunteers with non alcohol dependance. HRE following induction of alcohol craving and questionnaires
Outcomes
Primary Outcome Measures
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)).
Secondary Outcome Measures
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.
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.
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.
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
Correlation between EEG-HR and fMRI networks at inclusion
Correlation between EEG-HR and fMRI networks at inclusion in patients and healthy volunteers
Full Information
NCT ID
NCT05275166
First Posted
March 2, 2022
Last Updated
March 28, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05275166
Brief Title
Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography
Acronym
CRAVING-NET
Official Title
Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Dependence
Keywords
alcoholism, electroencephalography, brain activity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
Patients hospitalized for rehab. HRE following induction of alcohol craving and questionnaires
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Healthy Volunteers with non alcohol dependance. HRE following induction of alcohol craving and questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Induction of alcohol craving
Intervention Description
Presentation of images that may induce craving for alcohol. Recording of brain activity
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Questionnaires related to alcohol, quality of life, anxiety and depression
Primary Outcome Measure Information:
Title
Source connectivity within large-scale brain networks
Description
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)).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Variation in source connectivity based on AUQ
Description
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.
Time Frame
1 day
Title
Variation in source connectivity based on OCDS
Description
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.
Time Frame
1 day
Title
Variation in source connectivity based on psychological state
Description
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.
Time Frame
1 day
Title
Correlation between brain networks estimated by HRE and AUQ and OCDS scores
Description
Correlation between brain networks estimated by EEG-HR and AUQ and OCDS scores at 6 months only in patients
Time Frame
6 months
Title
Correlation between EEG-HR and fMRI networks at inclusion
Description
Correlation between EEG-HR and fMRI networks at inclusion in patients and healthy volunteers
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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;
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)
Exclusion Criteria:
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);
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure Gervais, Dr
Phone
299282591
Ext
+33
Email
marie-laure.gervais@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Moirand, Pr
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHU Rennes
Phone
0299282591
First Name & Middle Initial & Last Name & Degree
Romain Moirand, Pr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography
We'll reach out to this number within 24 hrs