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Péremption des unités de traitement prévue début juin 2026. Compte tenu des délais de traitement, aucune administration ne sera plus possible après le 1 février 2026. Ces facteurs ne permettent plus de garantir la poursuite des inclusions.
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The non-psychotomimetic cannabis compound cannabidiol (CBD) has been found effective for reducing alcohol drinking in mice. Moreover, other experimental studies have found that CBD reduced alcohol-induced steatosis in the liver, and reduced alcohol-related injury in the brain. Despite these promising results from animal data, no human study has been conducted yet in alcohol use disorder (AUD).
CBD has several potential therapeutic prospects in AUD. Preclinical studies now support the potential of CBD for drinking reduction in AUD subjects. Moreover, other experimental studies have found that CBD reverse the alcohol-induced steatosis process in the liver. These two experimental effects need a translational confirmation in humans through an explanatory phase 2 study. In addition, CBD could also exert neuroprotective effects that reduce the deleterious effects of alcohol on the brain. In both the liver and the brain, the idiosyncratic anti-inflammatory effects of CBD could thus strengthen the overall harm reduction allowed by drinking reduction in AUD ± ALD patients.
CBD deserves an exploratory study assessing whether the different therapeutic prospects in AUD are warranted. Moreover, because CBD is extracted from cannabis, and even if it is a CB1 antagonist with no psychotomimetic effects and no reported potential for abuse, the first pieces of evidence in AUD should confirm that CBD is safe in AUD subjects.
The CARAMEL study is a phase-2 clinical trial on 76 subjects, which aims to investigate the efficacy of CBD on reducing alcohol drinking, as well as the potential of CBD for restraining alcohol-induced brain and liver injuries, and confirm the good safety profile of CBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol (CBD) | Experimental | CBD Group from 20mg x 2/day up to 600mg/day |
|
| PLACEBO (PCB) | Placebo Comparator | PCB Group from 20mg x 2/day up to 600mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol oral oil | Drug | The CBD dosing used in the CARAMEL study will start at 40mg/d up to 600 mg/d. Oral oil contain 20 mg of CBD. 20 mg because our supplier does not have a more highly dosed oral oil. |
| Measure | Description | Time Frame |
|---|---|---|
| the total consumption of alcohol (in standard-drinks, sd) in the 28 last days (week 8 to week 12) of the study, using the Alcohol Timeline Followback (A-TLFB) daily self-report of alcohol drinking | The difference between the total alcohol consumption during 28 days preceding the study, and the 28 last days of the study, will be compared between the two groups. | Five months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference (i.e., inclusion minus end of study) in alcohol craving scores using the Obsessive Compulsive Drinking Scale (OCDS). | Inclusion minus end of study using the OCDS. The Obsessive Compulsive Drinking Scale (OCDS) is a 14-item questionnaire that measures an individual's alcohol use and his/her attempts to control his/her drinking. Each item is scored on a scale from 0 to 4.Obsessive subscale is the summation of items 1-6.Compulsive subscale is the summation of items 7-14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin ROLLAND, MD, PhD | Centre Hospitalier le Vinatier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Le Vinatier | Bron | Auvergne-Rhône-Alpes | 69678 cedex | France |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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CARAMEL is a phase-2, national, multi-site, interventional (category 1), double-blind, randomized, placebo-controlled trial, conducted in 76 subjects.
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CLEAVER LEAVES - ECOMEDICS SAS produce Oral oil of Cannabidiol and Placebo of similar galenic form. They will be responsible for the pharmaceutical analyses of the product.
Eurofins-LC2 will import the oral oil after authorization from the ANSM, and will relabeled individual vials for each participant, and regular dispatching into the hospital pharmacy.
Local hospital pharmacies will be in charge to deliver treatment individual vials to the investigators for dispensing.
| Placebo oral oil | Drug | Placebo of similar cannabidiol galenic form |
|
| Five months |
| Difference in alcohol use disorder scores using the Alcohol Use Disorders Identification Test scale (AUDIT-C). | inclusion minus end of study The Alcohol Use Disorders Identification Test (AUDIT-C) is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). Probable misuse: score > 4 for men and > 3 for women. Probable dependence: score > 10 regardless of sex. | Five months |
| Difference in anxiety and depression Hospital Anxiety and Depression Scale (HADS) | Inclusion minus end of study Each answer corresponds to a number. By adding these numbers, we obtain a total score per column (anxiety and depression). If the score of a column is greater than or equal to 11, it means that the subject suffers from anxiety or depression | Five months |
| Difference in Controlled Attenuation Parameter (CAP) scores | Inclusion minus end of study Using ultra-sound electrography which measures liver steatosis using transient ultra-sound elastography, between V0 and V4 | Five months |
| Change in steatosis scores between V0 and V4, using Proton Density Fat Fraction (PDFF) estimated on the structural liver based on Chemical Shift Encoding-MRI (CSE-MRI) and MR Spectroscopy (MRS). | Inclusion minus end of study | Five months |
| Between-group comparison of recovery of grey matter integrity in corticostriatal-limbic circuits, between V0 and V4, using MRI Voxel Based Morphometry (VBM) and cortical thickness measures. | Inclusion minus end of study | Five months |