RECRUITINGPhase 2INTERVENTIONAL
Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH
Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation in Patients With Severe Alcohol Use Disorder: A Phase II Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patients hospitalized for a scheduled alcohol inpatient cessation
- Aged 18-75 years old
- Meeting DSM 5 criteria for severe AUD
- Willing to participate
- Signing a written willing to sign a consent form
- Patients with current social insurance
- For childbearing age, sexually active females: efficacious contraceptive method during treatment and up to seven days after treatment administration
Who Should NOT Join This Trial:
- • Patients already scheduled for long term residential care after acute alcohol inpatient detoxification, not able to maintain the outpatient follow up
- Patients not willing to attend post-discharge visits whatever the reason
- Any unstable medical condition at entry, such as delirium, acute hepatic failure, hypokalaemia, liver cirrhosis whatever the stage, acute or chronic severe renal failure or any 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 medication or need for medication with treatments metabolized by CYP 2C19 or CYP3A4 or UGT enzymes and having strong inhibitor/inducer properties (see list above), and/or current medication or need for medications containing valproate and derivates
- Any medical history of epileptic seizure
- Patients with current or past history of cardiac arrhythmias, myocardial infarction and stroke
- Any history of suicidal attempt in the past 5 years or a score ≥1 to the Suicidal Ideation Attributes Scale (SIDAS)
- To facilitate efficacy data interpretation, patients currently receiving or wanting to receive another approved pharmacological treatment aimed at alcohol abstinence maintenance (acamprosate, baclofene, disulfiram, nalmefene, naltrexone).
- Other major current DSM 5 severe substance use disorder (like opiates, cocaine, amphetamines, ...) except for tobacco, cannabis smoking and benzodiazepines use disorders
- Pregnancy and breast feeding
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Patients hospitalized for a scheduled alcohol inpatient cessation
* Aged 18-75 years old
* Meeting DSM 5 criteria for severe AUD
* Willing to participate
* Signing a written informed consent
* Patients with current social insurance
* For childbearing age, sexually active females: efficacious contraceptive method during treatment and up to seven days after treatment administration
Exclusion Criteria:
* • Patients already scheduled for long term residential care after acute alcohol inpatient detoxification, not able to maintain the outpatient follow up
* Patients not willing to attend post-discharge visits whatever the reason
* Any unstable medical condition at entry, such as delirium, acute hepatic failure, hypokalaemia, liver cirrhosis whatever the stage, acute or chronic severe renal failure or any 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 medication or need for medication with treatments metabolized by CYP 2C19 or CYP3A4 or UGT enzymes and having strong inhibitor/inducer properties (see list above), and/or current medication or need for medications containing valproate and derivates
* Any medical history of epileptic seizure
* Patients with current or past history of cardiac arrhythmias, myocardial infarction and stroke
* Any history of suicidal attempt in the past 5 years or a score ≥1 to the Suicidal Ideation Attributes Scale (SIDAS)
* To facilitate efficacy data interpretation, patients currently receiving or wanting to receive another approved pharmacological treatment aimed at alcohol abstinence maintenance (acamprosate, baclofene, disulfiram, nalmefene, naltrexone).
* Other major current DSM 5 severe substance use disorder (like opiates, cocaine, amphetamines, ...) except for tobacco, cannabis smoking and benzodiazepines use disorders
* Pregnancy and breast feeding
* Known hypersensitivity to the active substance or to any of the excipients (including PEG)
* Patients under guardianship
* Patients in exclusion periods of other trials
* Reversely, cannabis use or cannabis use disorders will not be an exclusion criteria
Treatments Being Tested
DRUG
Placebo
Placebo made by the same manufacturer to look like the active pills
DRUG
Half dose CBD
add-on cannabidiol (Echo Pharmaceutical, BV) 450 mg per day for 11 days during their inpatient stay
DRUG
Full dose CBD
add-on cannabidiol (Echo Pharmaceutical, BV) 900 mg per day for 11 days during their inpatient stay
Locations (12)
Hôpital Albert Chenevier
Créteil, Albert Chenevier, France
Hôpital Antoine Béclère
Clamart, Clamart, France
CHU Gabriel Montpied
Clermont-Ferrand, Clermont Ferrand, France
Hôpital Louis Mourier
Colombes, Colombes, France
Hôpital Avicenne
Bobigny, France, France
Hôpital Fernand Widal
Paris, France, France
Hôpital Hôtel-Dieu
Paris, Paris, France
Hôpital Cochin
Paris, Paris, France
Hôpital Saint Anne
Paris, Paris, France
Hôpital Bichat
Paris, Paris, France
Hôpital René Muret
Sevran, Sevran, France
Hôpital la Colombière
Montpellier, France