Actively Recruiting
Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-03
210
Participants Needed
12
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Randomized clinical trial of 11 days Cannabidiol versus placebo as an adjunctive treatment during inpatient alcohol detoxification to improve abstinence in patients with severe alcohol use disorder.
CONDITIONS
Official Title
Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized for a scheduled alcohol inpatient cessation
- Aged 18 to 75 years old
- Meeting DSM 5 criteria for severe alcohol use disorder
- Willing to participate in the study
- Able to provide written informed consent
- Have current social insurance
- For sexually active females of childbearing age: using an effective contraceptive method during treatment and up to seven days after treatment
You will not qualify if you...
- Scheduled for long-term residential care after acute alcohol inpatient detoxification and unable to maintain outpatient follow-up
- Not willing to attend post-discharge visits for any reason
- Presence of unstable medical conditions at entry such as delirium, acute hepatic failure, hypokalaemia, liver cirrhosis of any stage, acute or chronic severe renal failure, or acute psychiatric condition
- Liver enzymes (ALT and/or AST) above 3 times the upper limit of normal and/or bilirubin above 2 times the upper limit of normal
- Current or needed medication that are strong inhibitors or inducers of CYP 2C19, CYP3A4, or UGT enzymes, or medications containing valproate and derivatives
- History of epileptic seizures
- Current or past cardiac arrhythmias, myocardial infarction, or stroke
- History of suicidal attempt in the past 5 years or a score of 1 or more on the Suicidal Ideation Attributes Scale (SIDAS)
- Currently receiving or wanting to receive other approved pharmacological treatments for alcohol abstinence maintenance (acamprosate, baclofen, disulfiram, nalmefene, naltrexone)
- Other major severe substance use disorders (e.g., opiates, cocaine, amphetamines) except tobacco, cannabis smoking, and benzodiazepines use disorders
- Pregnancy or breastfeeding
- Known hypersensitivity to cannabidiol or any excipients including PEG
- Under legal guardianship
- Participation in exclusion periods of other trials
- Cannabis use or cannabis use disorders are not exclusion criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Hôpital Albert Chenevier
Créteil, Albert Chenevier, France, 94000
Actively Recruiting
2
Hôpital Antoine Béclère
Clamart, Clamart, France, 92140
Not Yet Recruiting
3
CHU Gabriel Montpied
Clermont-Ferrand, Clermont Ferrand, France, 63000
Actively Recruiting
4
Hôpital Louis Mourier
Colombes, Colombes, France, 92700
Withdrawn
5
Hôpital Avicenne
Bobigny, France, France, 93000
Not Yet Recruiting
6
Hôpital Fernand Widal
Paris, France, France, France
Actively Recruiting
7
Hôpital Hôtel-Dieu
Paris, Paris, France, 75004
Not Yet Recruiting
8
Hôpital Cochin
Paris, Paris, France, 75014
Not Yet Recruiting
9
Hôpital Saint Anne
Paris, Paris, France, 75014
Actively Recruiting
10
Hôpital Bichat
Paris, Paris, France, 75018
Withdrawn
11
Hôpital René Muret
Sevran, Sevran, France, 93270
Actively Recruiting
12
Hôpital la Colombière
Montpellier, France, 34090
Not Yet Recruiting
Research Team
F
Florence VORSPAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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