Cannabidiol for Reducing Drinking in Alcohol Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2026-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Cannabidiol (CBD)

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

Group Type EXPERIMENTAL

Cannabidiol oral oil

Intervention Type 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.

PLACEBO (PCB)

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

Group Type PLACEBO_COMPARATOR

Placebo oral oil

Intervention Type DRUG

Placebo of similar cannabidiol galenic form

Interventions

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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.

Intervention Type DRUG

Placebo oral oil

Placebo of similar cannabidiol galenic form

Intervention Type DRUG

Eligibility Criteria

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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).
* Person under tutorship or curatorship.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No