Updated May 2026 · ClinicalTrials.gov

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

Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH (NCT05860699) is a Phase 2 interventional studying Severe Alcohol Use Disorder (DSM 5), sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Severe Alcohol Use Disorder (DSM 5) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 210 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Severe Alcohol Use Disorder (DSM 5) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

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.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05860699), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05860699 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05860699?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05860699?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05860699. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05860699. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.