Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence

Exclusion Criteria

• •1. Current Substance dependence (illegal drugs) ICD-10 or DSM-IV
• •2. Intention to stop alcohol consumption immediately and permanently
• •3. Current or previous disease that could cause a clinically relevant hazard (e.g. pancreatitis, cirrhosis)
• •4. kidney stone disease
• •5. Current Treatment with psychotropic drugs or current psychiatric disorder in need of treatment
• •6. alcohol withdrawal symptoms (at Screening, visit 1 or visit 2) with CIWA-Ar-Score \> 6 points or arterial blood pressure \>160 mm Hg or diastolic blood pressure \> 100 mm Hg or heart rate \>105 bpm (when breath alcohol concentration 0 mg%)
• •7. history of epileptic seizure or delirium
• •8. routine laboratory parameters, indicating relevant liver-, pancreas- or kidney injury, an acute infection, anemia or lack of vitamins (ASAT, ALAT, lipase \> threefold of the standard at screening, Quick's value \< 70%, creatinine \> 120 µmol/l, eGFR \< 30 mol/min/1.73 m², leucocytes \> 13000/µl, haemoglobin \< 7.5 mmol/l (men) or 6.5 mmol/l (women), MCV \> 105 fl, calcium level at screening \> 2.7 mmol/l
• •9. body weight \> 120 kg (Screening)
• •10. Breath alcohol concentration at screening or visit 1 or visit 2 two times \> 0 mg% or drug screening two times positive for opiate, cannabis, cocaine, amphetamine, benzodiazepine
• •11. history of hypersensitivity to alcohol or one of the used medicinal products, of their ingredients or medicinal products with similar chemical structures
• •12. history of inefficient treatment with Acamprosate
• •13. participation in another clinical trial within the last 4 weeks before inclusion
• •14. disorders, which will not allow the subject to assess the character and importance or possible consequences of the clinical trial
• •15. pregnant or breastfeeding women
• •16. 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 ovariectomy on both sides with or without hysterectomy) - regular and correct use of a contraceptive method with an error Quote of \< 1 % per year (for example implants, depot injections, oral contraceptive, IUP). It has to be recognized that a combined oral contraception - in contrast to pure progesterone compounds - have a failure rate of \< 1 %. Hormone IUDs with a Pearl Index of 1 % are safer than copper IUDs. - sexual abstinence - vasectomy of the Partner)
• •17. participant is not expected to comply with the protocol (for example lacking compliance)
• •18. less than 200 cumulative work trials for alcohol (in constant attention task) on 1st alcohol self-administration day
• •19. specific contraindications for Acamprosate or Calcium Carbonate (according prescribing information)
• •1. hypercalcemia, e.g. due to hyperparathyroidism, overdosage vitamin D, paraneoplastic
• •2. renal insufficiency (eGFR \< 30ml/min/1.73m²), creatinine \>120 µmol/l
• •20. intake of Vitamin D compounds or cardioactive glycosides