Trial document




This trial has been registered retrospectively.
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  DRKS00003502

Trial Description

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Title

Comparison between the outcome of high frequent psychotherapeutic sessions and a regulary replapse prevention program in alcohol addicted patients.

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Trial Acronym

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URL of the Trial

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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.

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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.

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Organizational Data

  •   DRKS00003502
  •   2012/08/27
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  •   yes
  •   Approved
  •   2012-201N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   3 short psychotherapeutic contacts per week without a medicamentous relapse prevention.

    Evaluation of the therapeutical effects by using psychometric questionnaires after 14 days, 1 month, 3 months, 6 months, 9 months, 12 months.
  •   2 outpatient department contacts per month without a medicamentous relapse prevention.

    Evaluation of the therapeutical effects by using psychometric questionnaires after 14 days, 1 month, 3 months, 6 months, 9 months, 12 months.
  •   3 short psychotherapeutic contacts per week combined with a medicamentous relapse prevention.

    Evaluation of the therapeutical effects by using psychometric questionnaires after 14 days, 1 month, 3 months, 6 months, 9 months, 12 months.
  •   2 outpatient department contacts per month combined with a medicamentous relapse prevention.

    Evaluation of the therapeutical effects by using psychometric questionnaires after 14 days, 1 month, 3 months, 6 months, 9 months, 12 months.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rates of abstinence and cumulative abstinence times in the 4 study groups measured by a structured clinical interview.
Measuring times: after 14 days, after 1 month, after 3 months, after 6 months, after 9 months, after 12 months

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Secondary Outcome

- Reduction of alcohol craving in the 4 study groups measured with the Obsessive Compulsive Drinking Scale
Measuring times: after 14 days, after 1 month, after 3 months, aufter 6 months, after 9 months, after 12 months.

- Comparison of levels of anxiety between the 4 study groups measured by the State Trait Anxiety Inventory (STAI)
Measuring times: after 14 days, after 1 month, after 3 months, aufter 6 months, after 9 months, after 12 months.


- Comparison of levels of depression between the 4 study groups measured by the Beck Depression Inventory (BDI)
Measuring times: after 14 days, after 1 month, after 3 months, aufter 6 months, after 9 months, after 12 months.


- Comparison of participants percieved stress between the 4 study groups measured by the Percieved Stress Scale (PSS)
Measuring times: after 14 days, after 1 month, after 3 months, aufter 6 months, after 9 months, after 12 months.


- Comparison of neuroendocrinological parameters between the 4 study groups
Measuring times: after 14 days, after 1 month, after 3 months, aufter 6 months, after 9 months, after 12 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   2012/06/05
  •   Actual
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- Fully Informed Consent
- Written Informed Consent
- Alcohol abstinence after inpatient or outpatient detoxification
- no current treatment requiring alcohol withdrawl syndrome

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Exclusion Criteria

- No Written Informed Consent
- Current dependence of illegal drugs
- Current suicidal tendency
- Severe somatic disease
- Participants needing a permanent medical treatment
- In Females: gravidity, lactation
- When taking a medicamentous relapse prevention: contraindications for the specific medication

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Addresses

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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Prof. Dr. med. Dipl. oec. med.  Falk  Kiefer 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Ms.  Anne  Koopmann 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmeidzin
    • Ms.  Anne  Koopmann 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentralinstitu für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Prof. Dr. med.  Falk  Kiefer 
    • J5
    • 68159  Mannheim
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.