A Phase 2 interventional study of BP1.3656 low dose and BP1.3656 intermediate dose in Alcohol Use Disorder, sponsored by Bioprojet. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Bioprojet · Phase 2, Interventional, and Treatment
A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 210 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Bioprojet is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
administration of BP1.3656 at 30 µg
Drug: BP1.3656 low dose
administration of BP1.3656 at 60 µg
Drug: BP1.3656 intermediate dose
administration of placebo
Drug: Placebo
administration of BP1.3656 at 90 µg
Drug: BP1.3656 high dose
Tablet, once daily oral administration at the low dose
Tablet, once daily oral administration at the intermediate dose
Tablet, once daily oral administration
Tablet, once daily oral administration at the high dose
Decrease in number of monthly Heavy Drinking Days (HDDs/month)
Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.
Time frame: 12 weeks
Total daily alcohol consumption (TAC)
Total daily alcohol consumption (TAC) from baseline to the end of treatment
Time frame: 12 weeks
Percent of patients without Heavy Drinking Days (HDDs)
Percent of patients without HDDs during the 12-week medication phase
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Bioprojet