CANNABINOL for Alcohol dependence

Inclusion criteria

• {"criterion_text":"- Males and females aged 18-65"}
• {"criterion_text":"- DSM-5 diagnosis of moderate or severe AUD."}
• {"criterion_text":"- Able to provide voluntary informed consent."}
• {"criterion_text":"- At least 8 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a man) in the 30 days prior to screen."}
• {"criterion_text":"- If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial."}
• {"criterion_text":"- Able to provide at least two locators."}
• {"criterion_text":"- Endorse desire to cut down or stop drinking."}
• {"criterion_text":"- Endorse desire to cut down or stop drinking."}

Exclusion criteria

• {"criterion_text":"- Current alcohol withdrawal (CIWA-Ar score >7)."}
• {"criterion_text":"- Pregnancy or lactation."}
• {"criterion_text":"- Current use of exclusionary medications, including cannabinoids; treatments for addictions including alcohol; moderate to strong inhibitors of CYP3A4 or CYP2C19; medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7; and medications with a narrow therapeutic index which are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, CYP2C19, CYP1A2, or CYP2B6."}
• {"criterion_text":"- Allergy to any ingredient of the study compound."}
• {"criterion_text":"- Current treatment for AUD, with exception of AA/12-step treatment/mutual-help groups-."}
• {"criterion_text":"- No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays."}
• {"criterion_text":"- A positive urine drug screen for THC, cocaine and/or opioids at screen."}
• {"criterion_text":"- Exclusionary medical conditions (e.g., current severe alcohol withdrawal requiring medical hospitalization, significantly impaired liver function)."}
• {"criterion_text":"- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder."}
• {"criterion_text":"- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)."}
• {"criterion_text":"- Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidally."}
• {"criterion_text":"- History of severe Traumatic Brain Injury (LOC > 24 hours)."}
• {"criterion_text":"- DSM-5 diagnosis of current mild cannabis use disorder and/or moderate or severe substance use disorder for a substance other than alcohol or nicotine."}
• {"criterion_text":"- Significant laboratory abnormalities, including significantly impaired liver function, serious abnormalities of complete blood count or metabolic panel."}
• {"criterion_text":"- Active legal problems likely to result in incarceration within 12 weeks of treatment initiation."}

Primary endpoints

• {"endpoint_text":"- To evaluate CBD efficacy on alcohol dependance","definition_or_measurement_approach":"Main objective specifies measurement: change in the Timeline Follow-back (TLFB) assessment of alcohol consumption and change in percent Carbohydrate Deficient Transferrin (CDT) in serum to evaluate therapeutic potential of CBD."}
• {"endpoint_text":"- To evaluate psychological symptoms involved in alcohol consumptions","definition_or_measurement_approach":"Secondary objectives describe use of self-reports of anxiety, depression, impulsivity, and alcohol craving to evaluate psychological symptoms."}
• {"endpoint_text":"- To evaluate endocannabinoid system","definition_or_measurement_approach":"Main/secondary objectives include determination of endocannabinoids in plasma and modifications in gene expression in peripheral blood mononuclear cells (PBMCs) to identify biomarkers associated with clinical changes."}
• {"endpoint_text":"- To evaluate CBD tolerability and safety in alcohol dependents","definition_or_measurement_approach":"Secondary objective: confirm tolerability and safety of CBD under the dose and pattern of administration (safety and tolerability assessments as described in protocol documents)."}

Spain

Earliest CTIS Part Ii Submission Date

01-07-2025

Latest Decision Or Authorization Date

30-09-2025

Processing Time Days

91

Number Of Sites

1

Number Of Participants

118

Primary sponsor

Full Name

Hospital Universitario 12 De Octubre

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Contract research organisations

Name

Start From Scratch S.L.

Responsibilities

sponsorDuties codes: 1,10,11,12,14,5,6,7,8 (as listed in submission); contact email: jarenas@sfscro.com

Third parties

• {"country":"Spain","full_name":"Start From Scratch S.L.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,14,5,6,7,8 (as listed in submission); contact email: jarenas@sfscro.com; phone: +34627513359","organisation_type":"Pharmaceutical company"}