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CBD-OH - Cannabidiol as an add-on treatment during inpatient alcohol cessation in patients with severe alcohol use disorder: a Phase II trial
EU CTIS ID: 2024-518455-28-00
What this study is testing
To increase abstinence maintenance rate at week 6 of the study (1 month after discharge of the scheduled alcohol withdrawal inpatient stay).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Patients hospitalized for a scheduled alcohol inpatient cessation
- 2) Aged 18-75 years old
- 3) Meeting DSM 5 criteria for severe AUD
- 4) Willing to participate
- 5) Signing a written informed consent
- 6) Patients with current social insurance
You likely can't join if
- 1) Patients already scheduled for long term residential care after acute alcohol inpatient detoxification, not able to maintain the outpatient follow up
- 10) Other major current DSM 5 severe substance use disorder (like opiates, cocaine, amphetamines, …..) except for tobacco and cannabis smoking and benzodiazepines use disorders.
- 11) Pregnancy and breast feeding
- 12) Known hypersensitivity to the active substance or to any of the excipients (including PEG)
- 13) Patients under guardianship
- 14) Patients in exclusion periods of other trials
See the full eligibility criteria
- 1) Patients hospitalized for a scheduled alcohol inpatient cessation
- 2) Aged 18-75 years old
- 3) Meeting DSM 5 criteria for severe AUD
- 4) Willing to participate
- 5) Signing a written informed consent
- 6) Patients with current social insurance
- 7) For childbearing age females: efficacious contraceptive method during treatment and up to seven days after treatment administration
- 1) Patients already scheduled for long term residential care after acute alcohol inpatient detoxification, not able to maintain the outpatient follow up
- 10) Other major current DSM 5 severe substance use disorder (like opiates, cocaine, amphetamines, …..) except for tobacco and cannabis smoking and benzodiazepines use disorders.
- 11) Pregnancy and breast feeding
- 12) Known hypersensitivity to the active substance or to any of the excipients (including PEG)
- 13) Patients under guardianship
- 14) Patients in exclusion periods of other trials
- 15) Reversely, cannabis use or cannabis use disorders will not be an exclusion criteria
- 2) Patients not willing to attend post-discharge visits whatever the reason
- 3) 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
- 4) 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
- 5) 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
- 6) Any medical history of epileptic seizure
- 7) Patients with current or past history of cardiac arrhythmias, myocardial infarction and stroke
- 8) any history of suicidal attempt in the past 5 years or a score ≥1 to the Suicidal Ideation Attributes Scale (SIDAS)
- 9) 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.