Validation of a test system for development of medications for alcoholism

Phase 1

• Conditions: 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: 19.0Level: HLTClassification code 10049180Term: Alcohol product useSystem Organ Class: 100000004869; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2015-002831-16-DE
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-13
• Study Completion: 2017-09-13
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

• 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 < 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 spirals with a Pearl Index of 1 % are safer than copper spirals. - sexual abstinence - vasectomy of the Partner
• evidence that the participant is not expected to comply with the protocol (for example lacking compliance)
• current or previous alcohol or substance dependence according to DSM-IV (exception: tobacco dependence)
• current or previous treatment because of alcohol, for example addiction advisory centre, self-help group, detoxification treatment
• current or previous diseases, where an alcohol infusion can cause a clinically relevant hazard (e. g. pancreatitis, liver cirrhosis)
• current or planned intake of opiate analgesics
• current psychiatric treatment or intake of psychiatric drug or suffering from of a psychiatric disease requiring treatment
• suicide attempts in the history
• CIWA-Score >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 < 15 mg/l, creatin indicating a moderate renal insufficiency ( eGFR <60 ml/min), leucocytes > 12000/µl, haemoglobin < 7,5 mmol/l (men) or 6,5 mmol/l (women), MCV > 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

Study & Design

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