Validation of a Test System for Development of Medications for Alcoholism

• Status: Completed
• Trial end date: 2017-09-04
• Target enrollment: 0
• Participant gender: All

Summary

Using theTEMA (test system for development of medications for alcoholism) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• male and female volunteers aged 25 to 55 years

• at least 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

Exclusion Criteria:

• a history of 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 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

• 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 in an addiction advisory cen-tre, 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

• a history of suicide attempt

• 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, amphetamines, 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 g/kg or twice >0,00 g/kg at visit 1

• unsuitable for fMRT (e. g. cardiac pacemaker, claustrophobia)

• 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