CANNABINOL for Alcohol dependence | Alcohol use disorder

Inclusion criteria

• {"criterion_text":"- Males and females aged 18-65\n- DSM-5 diagnosis of moderate or severe AUD.\n- Able to provide voluntary informed consent.\n- 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.\n- If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial.\n- Able to provide at least two locators.\n- Endorse desire to cut down or stop drinking.\n- Endorse desire to cut down or stop drinking."}

Exclusion criteria

• {"criterion_text":"- Current alcohol withdrawal (CIWA-Ar score >7).\n- Pregnancy or lactation.\n- 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.\n- Allergy to any ingredient of the study compound.\n- Current treatment for AUD, with exception of AA/12-step treatment/mutual-help groups-.\n- No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays.\n- A positive urine drug screen for THC, cocaine and/or opioids at screen.\n- Exclusionary medical conditions (e.g., current severe alcohol withdrawal requiring medical hospitalization, significantly impaired liver function).\n- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder.\n- 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).\n- 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.\n- History of severe Traumatic Brain Injury (LOC > 24 hours).\n- 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.\n- Significant laboratory abnormalities, including significantly impaired liver function, serious abnormalities of complete blood count or metabolic panel.\n- 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\n- To evaluate psychological symptoms involved in alcohol consumptions\n- To evaluate endocannabinoid system\n- To evaluate CBD tolerability and safety in alcohol dependents","definition_or_measurement_approach":"- To evaluate CBD efficacy on alcohol dependance: change in the Timeline Follow-back (TLFB) assessment of alcohol consumption and change in percent Carbohydrate Deficient Transferrin (CDT) in serum (as stated in main objective).\n- To evaluate psychological symptoms involved in alcohol consumptions: assessment via self-reports of anxiety, depression, impulsivity, and alcohol craving (secondary objectives reference these measures).\n- To evaluate endocannabinoid system: measure modifications in gene expression in peripheral blood mononuclear cells (PBMCs) and endocannabinoids in plasma to identify biomarkers associated with clinical changes (as stated in secondary objectives).\n- To evaluate CBD tolerability and safety in alcohol dependents: assessment of tolerability and safety under the dose and pattern of administration (safety/tolerability monitoring as stated in secondary objectives)."}

Spain

Earliest CTIS Part Ii Submission Date

04-12-2024

Latest Decision Or Authorization Date

16-12-2024

Processing Time Days

12

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

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","organisation_type":"Pharmaceutical company"}