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Recruiting Phase 2

Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH

NCT05860699 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2024-04-08
Last updated
2025-12-03

Condition(s) studied

Severe Alcohol Use Disorder (DSM 5)

Investigational drug(s) / intervention(s)

PlaceboHalf dose CBDFull dose CBD

Placebo: Placebo made by the same manufacturer to look like the active pills

Half dose CBD: add-on cannabidiol (Echo Pharmaceutical, BV) 450 mg per day for 11 days during their inpatient stay

Full dose CBD: add-on cannabidiol (Echo Pharmaceutical, BV) 900 mg per day for 11 days during their inpatient stay

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • clinical abstinence — Week 6
    examination ascertaining documented continuous abstinence (at each study visits assessing acute alcohol intoxication signs) up to month 1 after discharge, week 6 of the study
  • Self-decalred abstinence verified by the investigator — Week 6
    Self-declared abstinence using standardized TLFB (time line follow back) scales TLFB at screening visit and daily from Day 0 to Day 10 and 4 (1 per week) after discharge up to week 6 of the study).

Trial sites (12)

FacilityCityRegionStatus
Hôpital Albert Chenevier Créteil Albert Chenevier Recruiting
Hôpital Antoine Béclère Clamart Clamart Not Yet Recruiting
CHU Gabriel Montpied Clermont-Ferrand Clermont Ferrand Recruiting
Hôpital Louis Mourier Colombes Colombes Withdrawn
Hôpital Avicenne Bobigny France Not Yet Recruiting
Hôpital Fernand Widal Paris France Recruiting
Hôpital Hôtel-Dieu Paris Paris Not Yet Recruiting
Hôpital Cochin Paris Paris Not Yet Recruiting
Hôpital Saint Anne Paris Paris Recruiting
Hôpital Bichat Paris Paris Withdrawn
Hôpital René Muret Sevran Sevran Recruiting
Hôpital la Colombière Montpellier France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05860699 on ClinicalTrials.gov ↗ ← All trials in France