NCT05860699 Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH
| NCT ID | NCT05860699 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Severe Alcohol Use Disorder (DSM 5) |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2026-05-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 210 participants in total. It began in 2024-04-08 with a primary completion date of 2026-05-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Florence Vorspan
PRINCIPAL INVESTIGATOR
Département de Psychiatrie et de Médecine Addictologique, Hôpital Fernand Widal, AP-HP Inserm UMR-S 1144 Université de Paris FHU NOR-SUD
Frequently Asked Questions
Who can join the NCT05860699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Severe Alcohol Use Disorder (DSM 5). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05860699 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05860699 currently recruiting?
Yes, NCT05860699 is actively recruiting participants. Contact the research team at Florence.vorspan@aphp.fr for enrollment information.
Where is the NCT05860699 trial being conducted?
This trial is being conducted at Créteil, France, Clamart, France, Clermont-Ferrand, France, Colombes, France and 8 additional locations.
Who is sponsoring the NCT05860699 clinical trial?
NCT05860699 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Florence Vorspan at Département de Psychiatrie et de Médecine Addictologique, Hôpital Fernand Widal, AP-HP Inserm UMR-S 1144 Université de Paris FHU NOR-SUD. The trial plans to enroll 210 participants.