alcohol use disorder alcoholism
Conditions
Interventions
Beside treatment with the study medication (either placebo or active medication
BP1.3656 30 µg or 60 µg once daily, per os), patients have to follow cognitive
behavioral therapy (CBT) during the fir
addiction
alcohol use disorder
reduce alcohol consumption
Sponsors
Bioprojet Pharma
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male of female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI plus); 2. Ages 18-65; 3. Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale
Exclusion criteria
Exclusion criteria: 1. History of delirium tremens, epilepsy, or withdrawal seizures; 2. Clinical depression or suicidality; Beck Depression Inventory (BDI) * 16 and suicidality (item G * 0); 3. Recent illicit drug use, i.e. cannabis, cocaine, amphetamine or opiods; 4. 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 > 3 ULN) 5. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes; 6. HIV positive; HCV postive; HBsAg postive; 7. History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse; 8. Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox; 9. Receiving ongoing alcohol use disorder medication (e.g. Baclofen); 10. 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, such as Parkinson*s disease; 11. Known history of syncope, arrhytmia, myocardial infarction or any known significant ECG abnormality; 12. Known hypersensitivity to the tested treatment including active substance and excipients; 13. Participation in clinical trials and receipt of investigational drug(s) during previous 60 days, except as explicitly approve by the principal investigator; 14. Insufficient medical insurance according to local regulations; 15. Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women; 16. Male subject who want to conceive a child during the duration of the study up until 21 days after study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the decrease in number of monthly heavy drinking days (HDD: * 60 g/day in men and * 40 g/day) form baseline to end of the double blind randomization phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters in this study are: * Total daily alcohol consumption (TAC: total alcohol consumption) from baseline to end of treatment; * Percent of patients without heavy drinking days during the 12 weeks double-blind, randomized treatment (continuous controlled drinking= CCD); * Percent of Abstinent Days during the 12 weeks double-blind, randomized treatment (PAD: percent of abstinent days); * Continuous Abstinence Duration during the 12 weeks double-blind, randomized treatment (CAD: continuous abstinence duration); * 4-week point prevalence abstinence at end of treatment; * Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during the 12 weeks double-blind, randomized treatment; * Craving (Obsessive Compulsive Drinking Scale) during the 12 weeks double-blind, randomized treatment; * Beck Depression Inventory (BDI) during the 12 weeks double-blind, randomized treatment; * Treatment retention during the 12 weeks double-blind, randomized treatment; * Safety will be assessed by evaluation of treatment emergent adverse events (TEAE), physical examinations, clinical laboratory tests (blood chemistry, hematology and urinalysis), subsequent end of treatment potential withdrawal, evaluation scales and physical examination, measurement of heart rat, blood pressure and body weight at each study visit. If at ECG Fridericia's corrected QT-interval *500 ms, or if difference to baseline is * 60ms, it will be required to check ECG by second measurement. | — |
Countries
Bulgaria, France, Netherlands, Russian Federation
Outcome results
None listed