Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05159830

Cannabidiol for Reducing Drinking in Alcohol Use Disorder

Led by Hôpital le Vinatier · Updated on 2025-02-27

76

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Cannabidiol for Reducing Drinking in Alcohol Use Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 65 years
  • Fluent in French
  • Read the information procedure and signed informed consent
  • Affiliated with health insurance
  • Meet DSM-5 criteria for Alcohol Use Disorder (all stages)
  • Average drinking of at least 12 standard drinks per day over the month before inclusion (total of 336 standard drinks in 28 days)
Not Eligible

You will not qualify if you...

  • Abstinent for at least one day during the month before inclusion
  • Liver cirrhosis classified as Child-Pugh B or C
  • Diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Current suicidality or lifelong history of suicide attempts
  • History or current other substance use disorder (except alcohol or nicotine)
  • Use of cannabis or cannabinoids within 60 days before screening
  • Liver enzyme elevations above 3 times normal and bilirubin above 2 times normal
  • Impaired medical condition as judged by investigator
  • Pregnancy, breastfeeding, or insufficient contraception
  • Diagnosis of cancer, HIV, pulmonary arterial hypertension, epilepsy, or certain drug interactions
  • History of stroke, cardiac arrhythmias, or myocardial infarction
  • Use of certain AUD medications within 30 days prior to screening
  • MRI contraindications such as pacemaker or cochlear implant
  • Known allergy to cannabidiol or excipients
  • Under legal guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Le Vinatier

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

Actively Recruiting

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Research Team

F

Florelle BERTRAND

CONTACT

V

Véronique VIAL

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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