Investigation of the efficacy of acamprosate and calcium in comparison to placebo as validation of a behavioural test for alcohol dependence (TEMACA)

Phase 1

• Conditions: persons with disturbance in alcohol use according DSM5 which do not want to change their alcohol consumption; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2018-001386-16-DE
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-29
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

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

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 < 70 %, creatinine > 120 µmol/l, eGFR < 30 ml/min/1.73 m2, leukocytes above 13000/µl, haemoglobin < 7mmol/l (men) or < 6.5 mmol/l (women), MCV > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified