Clinical trial NCT05275166: Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography
Official title: Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcoholism
Alcohol Dependence
Keywords: alcoholism
electroencephalography
brain activity
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 0
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Source connectivity within large-scale brain networks
timeFrame: 1 day
Secondary outcomes:
measure: Variation in source connectivity based on AUQ
timeFrame: 1 day
measure: Variation in source connectivity based on OCDS
timeFrame: 1 day
measure: Variation in source connectivity based on psychological state
timeFrame: 1 day
measure: Correlation between brain networks estimated by HRE and AUQ and OCDS scores
timeFrame: 6 months
measure: Correlation between EEG-HR and fMRI networks at inclusion
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: CHU Rennes
name: Romain Moirand, Pr
role: PRINCIPAL_INVESTIGATOR
References: