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

NCT05275166 | Withdrawn

• 1 other identifier: 35RC21_9740_CRAVING-NET
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcoholism; Alcohol Dependence

Keywords

alcoholism; electroencephalography; brain activity

Outcome Measures

Primary Outcomes (1)

• 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)).

  1 day

Secondary Outcomes (5)

• Variation in source connectivity based on AUQ

  1 day

• Variation in source connectivity based on OCDS

  1 day

• Variation in source connectivity based on psychological state

  1 day

• Correlation between brain networks estimated by HRE and AUQ and OCDS scores

  6 months

• Correlation between EEG-HR and fMRI networks at inclusion

  1 day

Study Arms (2)

Patients

OTHER

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

Behavioral: Induction of alcohol craving; Other: Questionnaires

Healthy Volunteers

OTHER

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

Behavioral: Induction of alcohol craving; Other: Questionnaires

Interventions

Induction of alcohol craving BEHAVIORAL

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

Healthy Volunteers; Patients

Questionnaires OTHER

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

Healthy Volunteers; Patients

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Romain Moirand, Pr

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-11