German Clinical Trials Register

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Brief summary in lay language

In this study we want to compare the outcome of different relapse prevention programs for alcohol addicted patients. After detoxification in our department patients can choose between 4 different ambulant relapse prevention programs. On the one hand they have the opportunity to join 3 short contacts per week in our outpatient department. On the other hand they can choose a relapse prevention program with only 2 contacts per month in our outpatient department. Besides the contacts to our outpatient department patients have the opportunity to get specific medication for relapse prevention such as acamprosat or naltrexone. To evaluate the outcome of the therapy programs we will test the liver function by taking blood after 14 days, 1, 3, 6, 9 and 12 month. Additionally, we will do some tests for urinary ethylglucuronide. Using ethylglucuronide we can detect alcohol consumption in the last 3 days before the test. The aim of the present study is to evaluate the outcome of the different relapse prevention programs in 100 patients. After the end of the study the patients were assigned to 4 different study groups depending on the relapse prevention program they had chosen. After that the outcome of the 4 different study groups were compared. In the analyse we focus especially on alcohol craving and levels of anxiety, stress and depression at the different measuring times.

Brief summary in scientific language

The participants of the study will be alcohol dependent outpatients who had passed through a detoxification in our department. All patients will informed about the course and the aims of the study. The study was approved by the local ethics committee and was conducted according to the Declaration of Helsinki. All procedures were carried out with the adequate understanding and written consent of the participants. After detoxification the participants decide in cooperation with their physician independently from the study, in which relapse prevention program they want to take part (3 short contacts per week in our outpatient department vs. 2 contacts per month in our outpatient department). Both forms of relapse prevention can be combined with a specific medication for relapse prevention such as acamprosat or naltrexone and visits in a self-help group. To evaluate the outcome of the therapy programs routine laboratory data, including γGT, GOT and GPT will be collected after 14 days, 1, 3, 6, 9 and 12 month. Additionally, urinary ethylglucuronide will tested in an irregular rhythm to detect alcohol consumption in the last 3 days before the test. The aim of the present study is to evaluate the outcome of the different relapse prevention programs in 100 patients. After the end of the study the patients were assigned to 4 different study groups depending on the relapse prevention program they had chosen. After that the outcome of the 4 different study groups were compared. In the analyse we focus especially on alcohol craving and levels of anxiety, stress and depression at the different measuring times. Alcohol craving, symptoms of depression as well as the perceived stress level were objectified by giving specific psychometric questionnaires to the participants at each measuring time. Additionally to the above mentioned blood samples we will also collect a blood sample for measuring neuroendocrinological parameters such as cortisol, ACTH orexin, leptin and ghrelin. Because of the circadian rhythm of the neuroendocrinological parameters all blood samples will be taken in the morning.