Status:
RECRUITING
Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Severe Alcohol Use Disorder (DSM 5)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Primary objective: To increase abstinence maintenance rate at week 6 of the study (1 month after discharge of the scheduled alcohol withdrawal inpatient stay). Primary Endpoint: Percentage of patien...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
April 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 23 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05860699
Start Date
April 8 2024
End Date
May 23 2026
Last Update
December 3 2025
Active Locations (12)
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1
Hôpital Albert Chenevier
Créteil, Albert Chenevier, France, 94000
2
Hôpital Antoine Béclère
Clamart, Clamart, France, 92140
3
CHU Gabriel Montpied
Clermont-Ferrand, Clermont Ferrand, France, 63000
4
Hôpital Louis Mourier
Colombes, Colombes, France, 92700