male and female volunteers aged 25-55 years with moderate risky alcohol consumption of at least 41 g/day (men) or 31 g/day (women), according to European Medicines Agency (EMA, 2010) this is at least medium risk level of alcohol consumption MedDRA version: 19.0 Level: HLT Classification code 10049180 Term: Alcohol product use System Organ Class: 100000004869
Conditions
Interventions
Trade Name: Adepend 50 mg Filmtabletten
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Adepend 50 mg Filmtablette
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • voluntary men and women with age of 25 till 55 years • at least a weekly alcohol consumption at a medium risk level according to WHO in the Timeline Follow-back Interview over the last 45 day with an average amount of alcohol of 41 g/day (men) or 31 g/day (women) • at least 6 days with an alcohol consumption of >100 g/day (men) or 75 g/day (women) and at least 4 non consecutive alcohol abstinent days in the last 45 days • at least 1 drinking day in each full week between screening and visit 1 and not more than 6 abstinent days in the week before visit 1 • no demand of treatment of the risky alcohol consumption • written consent after Information Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • anamnestic known hypersensitivity against alcohol or one of the used medicinal products, of their ingredients or medicinal products with similar chemical structures • participation in another clinical trial within the last 4 weeks before inclusion • addiction or other disorders, which will not allow the subject to assess the character and importance or possible consequences of the clinical trial • pregnant or breastfeeding women • women capable of bearing children, except women who fulfil following criteria:- post-menopausal (12 months natural amenorrhoea or 6 month amenorrhoea and Serum FSH >40 ml U/ml) - post operative (6 weeks after ovarectomy on both sides with or without hysterectomy) - regular and correct use of a contraceptive method with an error Quote of 5 at Screening (alcohol withdrawal scale) • a history of symptoms of alcohol withdrawal, epileptic seizures or delirium • routine laboratory Parameters, indicating relevant liver-, pancreas- or kidney injury, an acute infection, anaemia or lack of vitamins (ASAT, ALAT > twofold of the standard at screening, gamma-GT, lipase >threefold of the standard, CRP 12000/µl, haemoglobin 100 fl) • Body weight > 130 kg • drug screening in urine: once positive at screening for opiate, cannabis, cocaine, amphet-amines, benzodiazepines or positive once at visit 1 for opiates or positive twice at visit 1 for cannabis, cocaine, amphetamines, benzodiazepines • breath alcohol concentration at screening once > 0,00 per mille or twice >0,00 per mille at visit 1 • unsuitable for fMRT (e. g. cardiac pacemaker, claustrophobic) • specific contraindications against naltrexone: o acute Hepatitis o severe or acute liver disease o severe kidney disease o rare hereditary galactose intolerance, Lapp-lactase-deficiency or Glucose-galactose-malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: With TEMA (test system for development of medications for alcoholism) it can be shown, that naltrexone (NTX) administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment;Primary end point(s): Difference of cumulative number of work sets for alcohol in the “constant attention task” (in verum and placebo group) between visit 1 and visit 2;Timepoint(s) of evaluation of this end point: visit 1: 7 - 42 days after Screening or 1-42 days after re-screening visit 2: 7 - 10 days after visit 1;Secondary Objective: It should be analysed, if - administration of naltrexone in comparison to placebo leads to a reduction of 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 OPRM1-polymorphism - administration of naltrexone changes the basal and alcohol induced ability of inhibition - administration of naltrexone changes the basal and alcohol induced regional cerebral perfusion - administration of naltrexone changes the basal 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 selfadministration | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: visit 1: 7 - 42 days after Screening or 1-42 days after re-screening visit 2: 7 - 10 days after visit 1 visit 3: 10 -16 days after visit 1 but at least 3 days after visit 2 visit 4: 2-12 days after visit 3, visit 5: 31 -34 days after visit 1;Secondary end point(s): (1) Endpoints concerning efficiency - Difference between visit 1 and visit 2 of the “break point” in the “progressive work” schedule for the work for alcohol - Maximal achieved blood alcohol concentration (BAC) in alcohol self-administration at visit 1 and visit 2 - Difference between visit 1 and visit 2 of the cumulative number of work sets for sodium chloride solution in the “constant attention task” - Drinking habits measured with Timeline Follow-back Interview over 45 days before study start (measured at Screening or re-screening) and over the entire duration of intake of medicinal product (day 1 untill inclusive of last day of intake of medicinal product, day 28, measured at the follow up visit ): drinking days, amount of alcohol per drinking day and number of days with alcohol consump-tion over 60 g (men) or 48 g (women) - CDT – level: (carbohydrate-deficient transferrin), measured at visit 1 and visit 5 - Alcohol craving in daily routine (OCD – scale) measured at visit 1 and visit 4 - Difference in subjective alcohol effects between visit 1 and visit 2, measured with visual analogue scales (“Quizzer”) before, during and after the infusion - Capacity for motor impulse control during infusion of physiologic saline solution or alcohol (single-blinded), measured with the counting stroop task (in Verum and pla-cebo group) at visit 3 and 4 - Regional cerebral perfusion during infusion of sodium chloride solution or alcohol (single-blinded), measured with arterial spin labeling (ASL) under verum or placebo condition at visit 3 and 4. - Cerebral resting state activity during infusion of sodium chloride solution or alcohol (single-blinded), meas | — |
Countries
Germany
Contacts
Public ContactDepartment of Psychiatry and Psycho
Technische Universität Dresden
Outcome results
None listed