CANNABIDIOL for Severe alcohol use disorder

Inclusion criteria

• {"criterion_text":"- 1) Patients hospitalized for a scheduled alcohol inpatient cessation"}
• {"criterion_text":"- 2) Aged 18-75 years old"}
• {"criterion_text":"- 3) Meeting DSM 5 criteria for severe AUD"}
• {"criterion_text":"- 4) Willing to participate"}
• {"criterion_text":"- 5) Signing a written informed consent"}
• {"criterion_text":"- 6) Patients with current social insurance"}
• {"criterion_text":"- 7) For childbearing age females: efficacious contraceptive method during treatment and up to seven days after treatment administration"}

Exclusion criteria

• {"criterion_text":"- 1) Patients already scheduled for long term residential care after acute alcohol inpatient detoxification, not able to maintain the outpatient follow up"}
• {"criterion_text":"- 10) Other major current DSM 5 severe substance use disorder (like opiates, cocaine, amphetamines, …..) except for tobacco and cannabis smoking and benzodiazepines use disorders."}
• {"criterion_text":"- 11) Pregnancy and breast feeding"}
• {"criterion_text":"- 12) Known hypersensitivity to the active substance or to any of the excipients (including PEG)"}
• {"criterion_text":"- 13) Patients under guardianship"}
• {"criterion_text":"- 14) Patients in exclusion periods of other trials"}
• {"criterion_text":"- 15) Reversely, cannabis use or cannabis use disorders will not be an exclusion criteria"}
• {"criterion_text":"- 2) Patients not willing to attend post-discharge visits whatever the reason"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 6) Any medical history of epileptic seizure"}
• {"criterion_text":"- 7) Patients with current or past history of cardiac arrhythmias, myocardial infarction and stroke"}
• {"criterion_text":"- 8) any history of suicidal attempt in the past 5 years or a score ≥1 to the Suicidal Ideation Attributes Scale (SIDAS)"}
• {"criterion_text":"- 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)."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients in each group with documented continuous abstinence at month 1 after discharge, week 6 of the study. Continuous abstinence will be defined by patients self-report of alcohol 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)","definition_or_measurement_approach":"Continuous abstinence defined by patient self-report using standardized TLFB at screening and daily from Day 0 to Day 10 and weekly after discharge up to week 6."}
• {"endpoint_text":"- Furthermore, this self-declaration will be confirmed by clinical examination at each study visits assessing acute alcohol intoxication signs and 6 ethyl glucuronide (Et-OH) urinary assessments performed at each study visit (2 during the inpatient stay and 4 (1 per week) after discharge up to week 6 of the study).","definition_or_measurement_approach":"Confirmation by clinical examination for signs of acute alcohol intoxication and 6 urinary ethyl glucuronide (Et-OH) assessments (2 inpatient, 4 post-discharge weekly up to week 6)."}

Secondary endpoints

• {"endpoint_text":"- symptoms check list (PRISE-M) of possible side effects every day from day 1 to 10, and then at each outpatient study visit (4 (1 per week) after discharge up to week 6 of the study). Thus any side effect related to treatment exposure as well as treatment cessation (such as anxiety rebound or withdrawal symptoms related to CBD or increase in cannabis use) could be documented","definition_or_measurement_approach":"PRISE-M daily from day 1 to 10, then at outpatient visits (weekly after discharge up to week 6) to document side effects and withdrawal/rebound symptoms."}
• {"endpoint_text":"- in case of relapse: drinking days and drinks per day (self-declared using standardized TLFB time line follow back scale over the past week) at the screening visit and daily from Day 0 to Day 10 and 4 (1 per week) after discharge up to week 6 of the study)","definition_or_measurement_approach":"Self-declared drinking days and drinks per day using TLFB at screening, daily Day 0-10, then weekly after discharge up to week 6."}
• {"endpoint_text":"- alcohol withdrawal scales and craving scales (CIWA-R, , LIKERT craving scale and an adapt version of the OCDS) at the screening visit and every day from day 0 to 10 then at each study visit: 4 (1 per week) after discharge up to week 6 of the study","definition_or_measurement_approach":"CIWA-R and craving scales (LIKERT, adapted OCDS) at screening, daily Day 0-10, then weekly post-discharge up to week 6."}
• {"endpoint_text":"- state anxiety scale (STAI-6 the short form of the Spielberger inventory, composed of 6 Likert scales) at the screening visit and every day from day 0 to 10 then at each study visit: 4 (1 per week) after discharge up to week 6 of the study","definition_or_measurement_approach":"STAI-6 administered at screening, daily Day 0-10, then weekly post-discharge up to week 6."}
• {"endpoint_text":"- Pittsburgh Sleep Quality Index (PSQI) at the screening visit and the last visit. A modified daily version every day from day 0 to 10 then at each study visit a modified weekly version: 4 (1 per week) after discharge up to week 6 of the study","definition_or_measurement_approach":"PSQI at screening and last visit; modified daily PSQI Day 0-10 and weekly thereafter up to week 6."}
• {"endpoint_text":"- in the subgroup of patients recruited in AP-HP hospitals, plasmatic level of CBD will be determined twice: at D5 and D10. Analysis of cannabinoids in human biological specimens of plasma will rely on an extraction process and a chromatographic separation in LCMSHR (Liquid chromatography coupled to high resolution mass spectrometry) for quantification of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), 11-OH THC and THC-COOH according to guidelines set forth by COFRAC.","definition_or_measurement_approach":"Plasma CBD levels measured at Day 5 and Day 10 using LCMSHR for quantification of THC, CBD, 11-OH THC and THC-COOH according to COFRAC guidelines."}
• {"endpoint_text":"- self-declared current use of all other substances including tobacco products and nicotine replacement therapies, cannabis, and other substances using standardized TLFB (time line follow back) scales ) at the screening visit and every day from day 0 to 10 then at each study visit: 4 (1 per week) after discharge up to week 6 of the study","definition_or_measurement_approach":"Self-declared use of other substances via TLFB at screening, daily Day 0-10, then weekly up to week 6."}
• {"endpoint_text":"- in the subgroup of patients who declare themselves as current cannabis users at entry, urinary quantitative determination of cannabinoids by an extraction process and a chromatographic separation in LCMSHR","definition_or_measurement_approach":"Urinary quantitative cannabinoid determination by extraction and LCMSHR in self-declared current cannabis users."}

Methods

• Recruitment of hospitalized patients undergoing a scheduled inpatient alcohol cessation at participating hospital sites in France (inclusion criterion: patients hospitalized for a scheduled alcohol inpatient cessation).

France

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

18-04-2025

Processing Time Days

182

Number Of Sites

11

Number Of Participants

210

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"[DGOS - Ministry of Higher Education and Research] : PHRC National_18-0777","duties_or_roles":"Monetary support (PHRC National_18-0777)","organisation_type":""}