Validation of a Test System for Development of Medications for Alcoholism

NCT02652585 | Completed Phase 3 DMC

• 1 other identifier: TUD-TEMANX-065
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism

Keywords

Alcoholism; alcohol self-administration

Outcome Measures

Primary Outcomes (1)

• Difference CAT Trials alcohol

  Difference of cumulative number of work sets for alcohol in the "constant attention task" between first measurement (without medication) and second measurement (with medication)

  one year

Secondary Outcomes (18)

• Difference CAT Trials sodium chloride solution

  one year

• break Point alcohol

  one year

• max. BAC

  one year

• Drinking habits

  one year

• CDT - level

  one year

Study Arms (2)

Naltrexone

ACTIVE COMPARATOR

1 capsule naltrexone 25 mg per day, oral use, day 1 to day 3; 1 capsule naltrexone 50 mg per day, oral use, day 4 to day 28

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

1 capsule placebo, oral use, day 1 to day 28

Drug: Placebo

Interventions

Naltrexone DRUG

Also known as: Adepend

Naltrexone

Placebo DRUG

capsule filled with micro crystalline cellulose, manufactured to mimic naltrexone capsule

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• a history of hypersensitivity against alcohol or one of the used medicinal products, of their ingredients or medicinal products with similar chemical structures
• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ulrich S Zimmermann, MD

  Klinik und Poliklinik für Psychiatrie und Psychotherapie Unversitätsklinikum Carl Gustav Carus Dresden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 12, 2016
• Study Start: February 1, 2016
• Primary Completion: August 25, 2017
• Study Completion: September 4, 2017
• Last Updated: September 27, 2017

Record last verified: 2017-09

Locations

DE (1)