Alcohol Use Disorder
Conditions
Brief summary
A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.
Detailed description
Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.
Interventions
DRUGBP1.3656 low dose
Tablet, once daily oral administration at the low dose
DRUGBP1.3656 intermediate dose
Tablet, once daily oral administration at the intermediate dose
DRUGPlacebo
Tablet, once daily oral administration
DRUGBP1.3656 high dose
Tablet, once daily oral administration at the high dose
Sponsors
Bioprojet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female alcohol use disorder * Ages 18-65 * Absent or minimal alcohol withdrawal symptoms assessed * 18 kg/m2 ≤ BMI ≤ 35 kg/m2 * Excessive alcohol use during the 2 weeks between screening and baseline * 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).
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in number of monthly Heavy Drinking Days (HDDs/month) | 12 weeks | Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total daily alcohol consumption (TAC) | 12 weeks | Total daily alcohol consumption (TAC) from baseline to the end of treatment |
| Percent of patients without Heavy Drinking Days (HDDs) | 12 weeks | Percent of patients without HDDs during the 12-week medication phase |
Countries
Bulgaria, France, Russia
Outcome results
None listed