Cannabidiol for Reducing Drinking in Alcohol Use Disorder

NCT05159830 | Terminated Phase 2 DMC

• 1 other identifier: 2019-004740-30
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

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

  Five months

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

  Five months

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

  Five months

• Difference in Controlled Attenuation Parameter (CAP) scores

  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).

  Five months

Study Arms (2)

Cannabidiol (CBD)

EXPERIMENTAL

CBD Group from 20mg x 2/day up to 600mg/day

Drug: Cannabidiol oral oil

PLACEBO (PCB)

PLACEBO COMPARATOR

PCB Group from 20mg x 2/day up to 600mg/day

Drug: Placebo oral oil

Interventions

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.

Cannabidiol (CBD)

Placebo oral oil DRUG

Placebo of similar cannabidiol galenic form

PLACEBO (PCB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).
• Person under tutorship or curatorship.

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678 cedex, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Benjamin ROLLAND, MD, PhD

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CARAMEL is a phase-2, national, multi-site, interventional (category 1), double-blind, randomized, placebo-controlled trial, conducted in 76 subjects.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: December 16, 2021
• Study Start: October 25, 2024
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)