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Report for Clinical Trial NCT02652585

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Validation of a Test System for Development of Medications for Alcoholism

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.

NCT02652585 Alcoholism
MeSH: Alcoholism

2 Interventions

Name: Naltrexone

Type: Drug

Naltrexone

Name: Placebo

Description: capsule filled with micro crystalline cellulose, manufactured to mimic naltrexone capsule

Type: Drug

Placebo


Primary Outcomes

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

Measure: Difference CAT Trials alcohol

Time: one year

Secondary Outcomes

Description: 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)

Measure: Difference CAT Trials sodium chloride solution

Time: one year

Description: 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.

Measure: break Point alcohol

Time: one year

Description: Maximal achieved blood alcohol concentration (BAC) in alcohol self-administration between first measurement (without medication) and second measurement (with medication)

Measure: max. BAC

Time: one year

Description: 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)

Measure: Drinking habits

Time: one year

Description: CDT - level: (carbohydrate-deficient transferrin), measured at visit 1 and visit 5

Measure: CDT - level

Time: one year

Description: Alcohol craving in daily routine (OCD - scale) measured at visit 1 and visit 4

Measure: alcohol craving

Time: one year

Description: 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

Measure: subjective alcohol effects

Time: one year

Description: 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

Measure: motor impulse control

Time: one year

Description: 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

Measure: cerebral blood flow (CBF)

Time: one year

Description: 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

Measure: Cerebral resting state activity

Time: one year

Description: Medical survey concerning occurring adverse events at visit 1 to 5

Measure: adverse events

Time: one year

Description: ALAT (alanine aminotransferase) in µmol/ s*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)

Measure: ALAT

Time: one year

Description: ASAT (aspartate aminotransferase) in µmol/ s*l before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)

Measure: ASAT

Time: one year

Description: Gamma-GT in µmol/ s*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)

Measure: Gamma-GT

Time: one year

Description: standard blood cell count before inclusion (screening visit), at visit 4 and after finishing all study relating interventions (visit 5)

Measure: standard blood cell count

Time: one year

Description: creatinine in µmol/l before inclusion (screening visit)

Measure: creatinine

Time: one year

Description: lipase in µmol/ s*l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)

Measure: lipase

Time: one year

Description: CRP (C-reactive protein) in mg / l before inclusion (screening visit) and after finishing all study relating interventions (visit 5)

Measure: CRP

Time: one year

Purpose: Basic Science

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 A118G

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 activity - changes of alcohol effects to the brain activity induced by naltrexone in comparison to placebo correlate with effects of naltrexone on the willingness to work for alcohol self-administration --- A118G ---



HPO Nodes