A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment (PoC Alcohol)

This is an interventional treatment trial for Alcohol Abuse, Nervous System Read More

Inclusion Criteria:

• Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus)
• Ages 18-65.
• Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale <10 at baseline assessment
• Normal weight: 18 kg/m2 ≤ BMI ≤ 35 kg/m2.
• Excessive alcohol use: number of heavy drinking days (≥ 60 g/day in men and ≥ 40 g/d in women) ≥15 during 30 days prior to screening and ≥7 during the 2 weeks between screening and baseline.
• Treatment-seeking, treatment goal: reduced drinking or abstinence
• If fertile, both males and females must agree to use effective birth control. Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding.
• Adequate social support according to the investigator to comply with the study requirements described in the protocol (e.g. transportation to and from trial site, self-rating scales, drug compliance, scheduled visits, etc.).
• Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05).
• Willing to receive psychosocial support

Exclusion Criteria:

• History of delirium tremens, epilepsy, or withdrawal seizures
• Clinical depression or suicidality: Beck Depression Inventory (BDI) < 16 and suicidality (Item G =0)
• Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids.
• Clinically significant cardiovascular, hematologic, severe hepatic impairment or (FLTs> 3 ULN), renal (Stage 2 and 3 according to international classification of renal kidney disease), neurological, endocrinological abnormalities or abnormal clinical laboratory results (in most cases > 3ULN).
• History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes.
• HIV positive; HCV positive; HBsAg positive
• History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
• Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox.
• Receiving ongoing alcohol use disorder medication (e.g. Baclofen)
• Other active clinically significant illness, which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation.
• Known history of syncope, arrhythmia, myocardial infarction or any known significant ECG abnormality
• Known hypersensitivity to the tested treatment including active substance and excipients.
• Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator.
• Insufficient medical insurance according to local regulations.
• Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women
• Male subject who wants to conceive a child during the duration of the study.