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Trial record 42 of 1665 for:    ( Map: Bulgaria )

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

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ClinicalTrials.gov Identifier: NCT03424824
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: BP1.3656 low dose Drug: BP1.3656 intermediate dose Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BP1.3656 low dose Drug: BP1.3656 low dose
Tablet, once daily oral administration at the low dose
Experimental: BP1.3656 intermediate dose Drug: BP1.3656 intermediate dose
Tablet, once daily oral administration at the intermediate dose
Placebo Comparator: Placebo Drug: Placebo
Tablet, once daily oral administration



Primary Outcome Measures :
  1. Decrease in number of monthly Heavy Drinking Days (HDDs/month) [ Time Frame: 12 weeks ]
    Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.


Secondary Outcome Measures :
  1. Total daily alcohol consumption (TAC) [ Time Frame: 12 weeks ]
    Total daily alcohol consumption (TAC) from baseline to the end of treatment

  2. Percent of patients without Heavy Drinking Days (HDDs) [ Time Frame: 12 weeks ]
    Percent of patients without HDDs during the 12-week medication phase



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424824


Contacts
Contact: Isabelle Lecomte, Dr +33 1 47 03 66 30 i.lecomte@bioprojet.com
Contact: Victoria Phamba +33 1 47 03 66 30 v.phamba@bioprojet.com

Locations
Bulgaria
State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism Recruiting
Sofia, Bulgaria, 1303
Contact: Sonya Toteva Zhenkova, Pr    +359 887 297 018    drtoteva@abv.bg   
Russian Federation
Leningrad Regional Narcology Dispensary Not yet recruiting
Leningrad, Russian Federation, 188661
Contact: Krupitsky Evgeny, Pr    007 (901) 300-5811    kruenator@gmail.com   
Sponsors and Collaborators
Bioprojet

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT03424824     History of Changes
Other Study ID Numbers: P15-01 / BP1.3656
2017-000069-57 ( EudraCT Number )
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Alcohol Drinking
Pathologic Processes
Drinking Behavior