EUCTR2015-002831-16-DE
Active, not recruiting
Phase 1
Validation of a test system for development of medications for alcoholism - TEMANX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Technische Universität Dresden
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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