Cannabidiol for reducing drinking in alcohol use disorder and modifying the effects of alcohol on the brain and the liver

Phase 1

• Conditions: CARAMEL is an exploratory phase-2 study conducted in subjects with AUD (alcohol use disorder) and current heavy drinking level, aiming to confirm the different properties of CBD observed in animal studies on models of AUD.; MedDRA version: 21.1Level: LLTClassification code 10001590Term: Alcohol addictionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-004740-30-FR
• Lead Sponsor: Centre Hospitalier Le Vinatier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-19
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Being aged 18 years, or more
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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

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
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
Lifelong history of cannabis use disorder (DSM-5 criteria)
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.
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).
Person under tutorship.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified