NCT03854942

Study of the Opioid Modulation of the Effect of Alcohol on the Dopaminergic Reward System

Opioid Modulation of the Effect of Alcohol on the Dopaminergic Reward System: a [18F]-Fallypride- and [18F]-Fluoro-DOPA-PET Study.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

About 10% of the calculable loss of health and quality of life in industrial countries can be attributed to excessive alcohol consumption. Behavioural pharmacological, genetic and clinical studies on alcohol dependence suggest a multifactorial model for the development of the disease, which ascribes an important role in the development of the disease to genetic variance, educational style and continued substance use. Animal and human experimental studies suggest that continued alcohol consumption leads to a pathological activation of the mesolimbic reward system. In the presented study, the modification of the alcohol-mediated activation of the mesolimbic reward system by the administration of the opiate antagonist naltrexone will be investigated in a human in vivo model. The aim is to gain important insights for the further development of pharmacological treatment options for alcohol dependence. Further development of pharmacological treatment options for alcohol dependence seems urgently necessary in order to slow down the high tendency to relapse and prolong the short abstinence period.

Conditions

• Alcohol Addiction

Interventions

Type	Name	Description
DRUG	Placebo	Placebo oral tablet daily
DRUG	Naltrexone	Naltrexone (Nemexin) oral tablet 50 mg daily for 2 days, Naltrexone (Nemexin) oral tablet 100 mg daily for 5 days

Timeline

• Start date: 2011-08-30
• Primary completion: 2017-12-13
• Completion: 2017-12-13
• First posted: 2019-02-26
• Last updated: 2019-09-12

Locations

1 site across 1 country: Germany