INTERVENTIONALTERMINATEDNCT05159830

Cannabidiol for Reducing Drinking in Alcohol Use Disorder and Modifying the Effects of Alcohol on the Brain and the Liver: a Phase 2 Clinical Trial.-The CARAMEL Study

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).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-12

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 10 (ACTUAL)
Start date: 2024-10-25
Sponsor: Hôpital le Vinatier
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Alcoholism

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Cannabidiol oral oil

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.

DRUG

Placebo oral oil

Placebo of similar cannabidiol galenic form

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Not accepted

Inclusion criteria

Being aged 18 - 65 years
Being fluent in French
Having read the information procedure and signed the informed consent sheet.
Being affiliated with health insurance.
DSM-5 criteria for AUD (all stages) (American Psychiatric Association, 2013)
Average drinking level of at least 12 standard-drinks (120g of ethanol) per day over the month prior to inclusion (i.e., a total alcohol consumption of 336 standard-drinks during the 28-day assessment period prior to inclusion), using the A-TLFB.

Exclusion criteria

At least one day of abstinence (no alcohol drinking) during the month prior to inclusion
Criteria for liver cirrhosis (Child-Pugh B or C)
DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, using the MINI 7.0.2.
Current suicidality, using the MNI 7.0.2
Lifelong history of suicide attempts
Lifelong history or current DSM-5 criteria for substance use disorder (other than alcohol or nicotine) using the MINI 7.0.2.
Any detected use of cannabis or any other cannabinoid within 60 days prior to screen
Patients with transaminase elevations greater than 3 times upper the limit of normal and bilirubin greater than 2 times upper the limit of normal.
Impaired medical condition (investigator's decision)
Pregnancy, lactation, or insufficient contraceptive measure (precautionary measure) (See 5.2 for acceptable birth control methods)
Patients with cancer, HIV, pulmonary arterial hypertension, epilepsy and with rifampicin, St. John's wort, Mammalian target of rapamycin (mTOR), calcineurin inhibitors or triazole antifungal agents like posaconazole, fluconazole… .
History of vascular accident and/or cardiac arrhythmias and/or myocardial infarction
Patients receiving acamprosate, naltrexone, disulfiram, nalmefene, topiramate, baclofen for AUD within 30 days prior to screening.
MRI contraindication: pacemaker, insulin pump, heart metal valve, cochlear implant…
Known hypersensitivity to the active principle (cannabidiol) or excipients (sucralose, menthol, mannitol).

primary outcomes

primary measures

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

Time frame: Five months

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.

secondary outcomes

secondary measures

Difference (i.e., inclusion minus end of study) in alcohol craving scores using the Obsessive Compulsive Drinking Scale (OCDS).

Time frame: Five months

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.

Difference in alcohol use disorder scores using the Alcohol Use Disorders Identification Test scale (AUDIT-C).

Time frame: Five months

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.

Difference in anxiety and depression Hospital Anxiety and Depression Scale (HADS)

Time frame: Five months

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

Difference in Controlled Attenuation Parameter (CAP) scores

Time frame: Five months

Inclusion minus end of study Using ultra-sound electrography which measures liver steatosis using transient ultra-sound elastography, between V0 and V4

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).

Time frame: Five months

Inclusion minus end of study

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 1c88b301-0993-434f-b74a-5be5896593b1
Retrieved: 11/09/2026, 14:14:59
SHA-256: 98fd28e0c6ac06fd869a3bf7ec84b4010aaad8f7a801a6be57b02aa561d5da56

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Cannabidiol oral oil

Placebo oral oil

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

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

secondary measures

Difference (i.e., inclusion minus end of study) in alcohol craving scores using the Obsessive Compulsive Drinking Scale (OCDS).

Difference in alcohol use disorder scores using the Alcohol Use Disorders Identification Test scale (AUDIT-C).

Difference in anxiety and depression Hospital Anxiety and Depression Scale (HADS)

Difference in Controlled Attenuation Parameter (CAP) scores

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).

Locally readable linked articles

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.