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New treatment option for Severe Alcohol Use Disorder (DSM 5)
Official title Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH
ClinicalTrials.gov ID: NCT05860699
What this study is testing
What is Half dose CBD?
Half dose CBD is an investigational medicine, given as an once-weekly, being studied as a potential treatment for severe alcohol use disorder (dsm 5).
Also referred to as Active half-dose for 11 days during inpatient alcohol cessation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Any medical history of epileptic seizure
See the full eligibility 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
- 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...
- 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 how well it works data interpretation, patients currently receiving or wanting to receive another approved pharmacological treatment aimed at alcohol abstinence maintenance (acamprosate, baclofene...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, Albert Chenevier, France
- Clamart, Clamart, France
- Clermont-Ferrand, Clermont Ferrand, France
- Colombes, Colombes, France
- Bobigny, France, France
- Paris, France, France
- Paris, Paris, France
- Sevran, Sevran, France
- Montpellier, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, Albert Chenevier, France; Clamart, Clamart, France; Clermont-Ferrand, Clermont Ferrand, France; Colombes, Colombes, France; Bobigny, France, France; Paris, France, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.