Clinical Trial: Validation of a Test System for Development of Medications for Alcoholism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Validation of a Test System for Development of Medications for Alcoholism

Brief Summary: Using theTEMA (test system for development of medications for alcoholism) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.

Detailed Summary:

Objective of this study is to show that a laboratory alcohol self-administration method can predict the therapeutic potential of new compounds to reduce relapse in alcohol-dependent patients.

The 'TEMA" translates several animal behavioral paradigms of alcohol self-administration into corresponding human experiments.

We will investigate the opiate antagonist Naltrexone, whose anti-relapse effect is well documented, as a reference drug for validation.

Main objective:

With TEMA (test system for development of medications for alcoholism ) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.

Secondary objectives:

  • administration of naltrexone in comparison to placebo leads to a reduction of alcohol craving and real-life drinking
  • administration of naltrexone in comparison to placebo leads to reduction of the CDT-Level
  • administration of naltrexone in comparison to placebo leads to a change in perception of subjective alcohol effects
  • the effectiveness of naltrexone can be predicted by the A118G polymorphism of the OPRM1
  • administration of naltrexone changes the baseline and alcohol-induced ability of motor inhibition
  • administration of naltrexone changes the baseline and alcohol-induced regional cerebral perfusion
  • administration of naltrexone changes the baseline and alcohol-induced cerebral resting state activi
    Sponsor: Technische Universität Dresden

    Current Primary Outcome: Difference CAT Trials alcohol [ Time Frame: one year ]

    Difference of cumulative number of work sets for alcohol in the "constant attention task" between first measurement (without medication) and second measurement (with medication)


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Difference CAT Trials sodium chloride solution [ Time Frame: one year ]
      Difference of cumulative number of work sets for sodium chloride solution in the "constant attention task" between first measurement (without medication) and second measurement (with medication)
    • break Point alcohol [ Time Frame: one year ]
      Difference of the "break point" in the "progressive work" schedule for the work for alcohol between first measurement (without medication) and second measurement (with medication). The "break point" is the number of the last alcohol request before subjects stop to work for more alcohol.
    • max. BAC [ Time Frame: one year ]
      Maximal achieved blood alcohol concentration (BAC) in alcohol self-administration between first measurement (without medication) and second measurement (with medication)
    • Drinking habits [ Time Frame: one year ]
      Drinking habits measured with Timeline Follow-back Interview over 45 days before study start (measured at screening) and over the entire study duration (between screening and the last day of medicinal product intake, ascertained at visit 5): drinking days, amount of alcohol per drinking day and number of days with alcohol consumption over 60 g (men) or 48 g (women)
    • CDT - level [ Time Frame: one year ]
      CDT - level: (carbohydrate-deficient transferrin), measured at visit 1 and visit 5
    • alcohol craving [ Time Frame: one year ]
      Alcohol craving in daily routine (OCD - scale) measured at visit 1 and visit 4
    • subjective alcohol effects [ Time Frame: one year ]
      Difference in subjective alcohol effects between first measurement (without medication) and second measurement (with medication), measured with visual analogue scales ("Quizzer") before, during and after the alcohol infusion
    • motor impulse control [ Time Frame: one year ]
      Capacity for motor impulse control during infusion of physiologic saline solution or alcohol as NIMPs (single-blinded), measured with the counting stroop task (in Verum and placebo group) at visit 3 and 4
    • cerebral blood flow (CBF) [ Time Frame: one year ]
      Regional cerebral perfusion in ml/100 g tissue per Minute during infusion of sodium chloride solution or alcohol as NIMPs (single-blinded), measured with arterial spin labeling (ASL) under verum or placebo condition at visit 3 and 4
    • Cerebral resting state activity [ Time Frame: one year ]
      Cerebral resting state activity during infusion of sodium chloride solution or alcohol as NIMPs (single-blinded), measured with BOLD fMRI (in Verum and placebo group) at visit 3 and 4
    • adverse events [ Time Frame: one year ]
      Medical survey concerning occurring adverse events at visit 1 to 5
    • ALAT [ Time Frame: one year ]
      ALAT (alanine aminotransferase) in µmol/ s*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)
    • ASAT [ Time Frame: one year ]
      ASAT (aspartate aminotransferase) in µmol/ s*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)
    • Gamma-GT [ Time Frame: one year ]
      Gamma-GT in µmol/ s*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)
    • standard blood cell count [ Time Frame: one year ]
      standard blood cell count before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)
    • creatinine [ Time Frame: one year ]
      creatinine in µmol/l before inclusion (screening visit)
    • lipase [ Time Frame: one year ]
      lipase in µmol/ s*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)
    • CRP [ Time Frame: one year ]
      CRP (C-reactive protein) in mg / l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)


    Original Secondary Outcome: Same as current

    Information By: Technische Universität Dresden

    Dates:
    Date Received: January 6, 2016
    Date Started: November 2015
    Date Completion: April 2017
    Last Updated: August 2, 2016
    Last Verified: August 2016