Study of the Neural Substrates of Alcohol Craving by High-resolution Electroencephalography

NCT ID: NCT05275166

Last Updated: 2023-12-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-11-30

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.

Conditions

Alcoholism; Alcohol Dependence

Keywords

alcoholism; electroencephalography; brain activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients

Patients hospitalized for rehab. HRE following induction of alcohol craving and questionnaires

Group Type: OTHER

Induction of alcohol craving

Intervention Type: BEHAVIORAL

Presentation of images that may induce craving for alcohol. Recording of brain activity

Questionnaires

Intervention Type: OTHER

Questionnaires related to alcohol, quality of life, anxiety and depression

Healthy Volunteers

Healthy Volunteers with non alcohol dependance. HRE following induction of alcohol craving and questionnaires

Group Type: OTHER

Induction of alcohol craving

Intervention Type: BEHAVIORAL

Presentation of images that may induce craving for alcohol. Recording of brain activity

Questionnaires

Intervention Type: OTHER

Questionnaires related to alcohol, quality of life, anxiety and depression

Interventions

Induction of alcohol craving

Presentation of images that may induce craving for alcohol. Recording of brain activity

Intervention Type: BEHAVIORAL

Questionnaires

Questionnaires related to alcohol, quality of life, anxiety and depression

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain Moirand, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Countries

France

Other Identifiers

35RC21_9740_CRAVING-NET

Identifier Type: -

Identifier Source: org_study_id