persons with disturbance in alcohol use according DSM5 which do not want to change their alcohol consumption
Conditions
Interventions
Product Name: Acamprosat-Calcium
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Acamprosat-Calcium
CAS Number: 77337-73-6
Current Sponsor code: Acamprosat-Calcium
Other descriptive name: 3-Ac
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female volunteers aged 25 to 55 years who are currently or have a history of fulfilling the diagnostic criteria of an have at least a mildly pronounced alcohol abuse disorder in accordance with DSM-5, but do not consume alcohol immediately and permanently to set the time. 2. Be willing to abstain continuously and completely from alcohol, sedatives and illicit drugs for 15-20 days for the purpose of study participation. 3. According to WHO, high-risk alcohol consumption with average drinking quantities for men: >60 g/day, for women >40 g/day in the timeline Follow-back interview over the last 45 days before the screening examination, spread over an average of at least 4 drinking days per week. 4. Written consent of the participating person after clarification has been given . 5. Successful attempt to swallow a placebo capsule of the investigational medicinal products during the screening visit. 6. No period of more than 6 consecutive abstinence days between the screening date and visit 2. 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 84 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Current, active dependence on illegal drugs, determined by medical questioning and comparison with the corresponding ICD-10s or DSM-IV criteria 2. on specific request, indicating interested parties to immediately and permanently cease alcohol consumption, irrespective of whether or not they participate in the study 3. known current or past conditions in which alcohol infusion or withdrawal could cause a clinically relevant hazard (e.g. pancreatitis, cirrhosis of the liver) determined by medical questioning and clinical examination 4. kidney stone disease in prehistory 5. current psychiatric treatment or use of psychotropic drugs or presence of a psychiatric patient in need of treatment illness 6. for screening or for V1 or V2 alcohol withdrawal signs with point value in the CIWA alcohol withdrawal scale > 6 or blood pressure systolic > 160 mm Hg or diastolic > 100 mm Hg or heart rate > 105/min, each at breath alcohol concentration of 0 per mille; 7. epileptic seizures or delirium in the anamnesis 8. deflection of routine laboratory parameters indicating a possible hazard from the study procedures: ASAT, ALAT, lipase each via three times the standard value, quick value 120 µmol/l, eGFR 105 fl, Ca2+ level at screening date > 2.7 mmol/l 9. weight > 100 kg for screening 10. positive twice > 0 per mille during screening or at visits 1, 2 or 3 breath alcohol concentration (AAK) or drug screening in urine twice positive on opiates, cannabis, cocaine, amphetamines, benzodiazepines. If the result is positive, the examination can be performed once on a later day. be repeated 11. a history of hypersensitivity to alcohol or any of the drugs used or their ingredients, or to medicaments having a similar chemical structure 12. Previous treatment trial with Acamprosat that was considered ineffective by the interested party or therapist. 13. participation of the subject in another clinical trial within the last 4 weeks prior to inclusion 14. diseases which do not allow the person concerned to assess the nature, extent and possible consequences of the clinical trial 15. pregnant or breastfeeding women 16. women of childbearing age, except women who meet the following criteria: a.Postmenopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH > 40 ml U/ml) b.Postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy) c.Regular and correct use of a contraceptive method with an error rate of < 1% per year (e.g. implants, depot syringes), intrauterine device (IUD). It should be taken into account that combined oral contraception - in contrast to pure progesterone preparations - is a has a failure rate of < 1%. Hormone spirals are safer than copper spirals with a Pearl Index < 1%. d.Sexual abstinence e.vasectomy of the partner 17. indications that the subject is unlikely to comply with the protocol (e.g. lack of cooperation) 18. In addition, specific contraindications to acamprosate or calciumcarbonate according to the technical information: a. Diseases or circumstances that may cause hypercalcemia or hypercalcuria, e.g. hyperparathyroidism, kidney stones containing calcium, nephrocalcinosis, prolonged immobilization with accompanying hypercalciuria or hypercalcemia. b. Renal insufficiency (eGFR < 30 ml/min/1.73 m2), creatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Validation of the behavior test "TEMA": Can the TEMA demonstrate that the administration of acamprosate or ionised calcium (Ca2+ = Calciumcarbonat) reduces the willingness to work after a period of abstinence from alcohol of at least 15 (to 20) days in order to be able to drink alcohol? ;Secondary Objective: 1. Does the administration of acamprosate or calcium in comparison to placebo lead to a changed subjective perception of alcohol effects? 2. Can the efficacy of Acamprosat or Ca2+ be predicted? 3. Can the administration of Acamprosat or Ca2+ reduce the alcohol demand in everyday life? 4. Are there differences between treatment groups in the frequency of alcohol consumption during the imposed abstinence period and how does this affect alcohol work after the imposed abstinence period? 5. Does participation in the study encourage motivation to change drinking habits or does it change drinking habits or the use of addiction services? 6. Is the activity of secreted sphingomyelinase suitable as a biomarker for alcohol consumption and prediction of drug action? 7. Do safety problems arise in the use of the investigational medicinal products?;Primary end point(s): The difference in the cumulative number of alcohol passes in the constant attention task between the first (V2) and second (V5) self-administration experiments compared between the groups treated with acamprosate vs. placebo or calcium vs. placebo. ;Timepoint(s) of evaluation of this end point: Values before the start of abstinence compared to values at the end of abstinence. Abstinence is 14 to 19 days. Visite 2 = Visite 1 (screening + 7-35 days) + 7-10 days compared with Visit 5 = Visit 4 (first day of medication) +13-18 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (A) Endpoints related to efficacy: 1. other parameters of alcohol self-administration a.Difference between first and second self-administration experiment in the break points in the progressive work scheme for the work for alcohol b.The difference of the maximum blood alcohol concentration (BAC) achieved between the first and second self-administration experiments c. The difference between the first and second self-administration experiments in the cumulative number of working passes for saline solution in the constant attention task. d.Investigation of the primary and the above-mentioned secondary parameters of alcohol self-administration with separate consideration only of the first or second half of the experiment 2. alcohol-induced change in values for subjective alcohol effects between first and second self-administration experiment, recorded by visual analogue scales ("quizzers") before, during and after the experiment in the 3 treatment groups 3. baseline values and changes in calcium supply parameters between V2 and V5 (blood levels of total calcium, phosphate, magnesium, albumin, parat-hormone, 25-hydroxy-vitamin D) in the three treatment groups in relation to the primary target quantity. 4. change of the alcohol demand in everyday life (by means of OCDS scores), measured in each case before both self-administration experiments in the 3 treatment groups 5. violations of imposed abstinence as a proportion (%) of days with alcohol consumption (as determined by Timeline Follow-Back Interview (TLFB)) in the three treatment groups and their influence on the primary target size 6. stage of change motivation regarding drinking habits (readiness to change questionnaire) for screening, visit 6 and telephone follow-up 7. drinking behaviour (using TLFB) for the period from 45 days prior to screening to one day prior to follow-up telephone examination 8. any reported use of the addiction ass | — |
Countries
Germany
Contacts
Public ContactKlinik & Poliklinik für Psychiatrie
Technische Universität Dresden
Outcome results
None listed