Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03424824
• Date of registration: 26/01/2018
• Prospective Registration: No
• Primary sponsor: Bioprojet
• Public title: Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
• Scientific title: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment
• Date of first enrolment: January 9, 2018
• Target sample size: 129
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03424824
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, France, Russian Federation

Contacts

• Name: Isabelle Lecomte, Dr

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Alcohol Use Disorder

Intervention(s)

Drug: Placebo

Drug: BP1.3656 intermediate dose

Drug: BP1.3656 low dose

Primary Outcome(s)

Decrease in number of monthly Heavy Drinking Days (HDDs/month) [Time Frame: 12 weeks]

Secondary Outcome(s)

Total daily alcohol consumption (TAC) [Time Frame: 12 weeks]

Percent of patients without Heavy Drinking Days (HDDs) [Time Frame: 12 weeks]

Secondary ID(s)

P15-01 / BP1.3656

2017-000069-57

Source(s) of Monetary Support

Please refer to primary and secondary sponsors