Clinical Trial: A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Multisite Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Pitolisant (BF2.649) For Alcohol Use Disorder Treatment

Brief Summary:

• The study primary end point is the decrease in the number of monthly heavy drinking days (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT).

• The Secondary end points will be designed to assess safety and tolerability and to further investigate the effect of pitolisant on other alcohol use criteria (e.g. total alcohol consumption, number of abstinence days), craving as well as the improvement in mental health (depression, sleep) and quality of life.

  • Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
  • Percent of patients without HDDs during the 24 weeks RT phase of the study. (Continuous Controlled Drinking=CCD)
  • Percent of Abstinent Days during RT phase (PAD)
  • Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD)
  • 4-week point prevalence abstinence at end of treatment
  • Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase
  • Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase
  • Beck Depression Inventory (BDI) during 24 week RT phase
  • Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase.
  • Treatment retention during 24 week RT
  • Quality of life (SF-12) during RT phase
  • Percent patients without HDDs during the OL
    

    Detailed Summary:
    Sponsor: Bioprojet
    

    Current Primary Outcome: Monthly Heavy Drinking Days (HDD/month) [ Time Frame: Change from Baseline of Monthly Heavy Drinking Days and at week 24 ]
    
    

    Original Primary Outcome: Same as current
    
    

    Current Secondary Outcome:

    • Total daily Alcohol Consumption (TAC) [ Time Frame: at week 24 versus Baseline ]
    • Percent of Abstinent Days during 24 weeks medication phase (PAD) [ Time Frame: at week 24 versus Baseline ]
    • Improvement in alcohol biomarkers (ALAT, ASAT, % CDT) [ Time Frame: at baseline , at week 4 , at week 8, at week 12, at week 16, at week 20 and at week 24. versus Baseline ]
    • Continuous Abstinence Duration during 24 weeks medication phase (CAD) [ Time Frame: at week 24 versus Baseline ]
    • Obsessive Compulsive Drinking Scale (OCDC) [ Time Frame: at week 24 versus Baseline ]
    • Time Line Follow Back (TLFB) [ Time Frame: at week 24 versus Baseline ]
    • Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: at week 24 versus Baseline ]
    • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: at week 24 versus Baseline ]
    • Quality of Life (SF-12) [ Time Frame: at week 24 versus Baseline ]
    
    
    

    Original Secondary Outcome: Same as current
    
    Information By: Bioprojet
    

    Dates:
    Date Received: June 7, 2016
    Date Started: October 2016
    Date Completion:
    Last Updated: January 11, 2017
    Last Verified: June 2016