Trial document




drksid header

  DRKS00005474

Trial Description

start of 1:1-Block title

Title

The adminstration of ear acupuncture according to the NADA protocol to patients with alcohol dependende

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

acupuncture001

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This study aims to investigate the effects of ear acupuncture according to the NADA protocol on craving, treatment adherence, anxiety, depression and psychophysiological parameters in patients alcohocol who are presently abstinent from alcohol. For this purpose 72 inpatients of a rehabilitation clinic will be included.
The patients will be randomized into three study groups: patients assigned to group 1 will receive ear acupuncture according to the NADA protocol. Patients of group two will receive placebo (sham) acupuncture and patients of group three will not receive any acupuncture.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The patients included will be randomized into three study groups: patients assigned to group 1 will receive ear acupuncture according to the NADA protocol. Patients of group two will receive placebo (sham) acupuncture and patients of group three will not receive any acupuncture. Measurements of psychometric and psychophysiological parameters will be performed at repeated time points prior to the six week acupuncture treatment phase and up to 4 weeks afterwards. Identical measurements will be conducted in patients who do not receive acupuncture at the same time points. All participants will receive multimodal postacute inpatient treatment. Abstinence from alcohol will be confirmed by alcohol breathing tests (Alkomattests).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005474
  •   2013/11/26
  •   [---]*
  •   yes
  •   Approved
  •   EK353092013, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   NADA ear acupuncture (20 sessions over 6 weeks)
  •   placebo (sham) acupuncture (20 sessions over 6 weeks)
  •   control (without acupuncture)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo, No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

heart rate variabilty (analysis of ECG and pulse wave)
3 time points of measurement: before start of first treatment and on the last treatment day as well as four weeks afterwards

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

craving, anxiety, depression, psychic symptom load, relaxation, skin condunctance, skin blood flow
Psychometric questionaires, skin resistance, photopletysmography
3 time points of measurement: before start of first treatment and on the last treatment day as well as four weeks afterwards

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2013/12/09
  •   72
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   72   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

alcohol dependence, staying abstinent from alcohol for at least five days

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

oral administration of a beta-blocker within 14 days prior to study begin, oral administration of antidepressants within three months prior to study begin, oral administration of anticoagulants within 14 days prior to study begin, diabetis mellitus, coronary heart disease, heart failure, dementia, schizophrenia, major depression or bipolar disorder, drug addiction, known metal allergy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychotherapie und Psychosomatik , Universitätsklinikum der TU Dresden
    • Mr.  Prof. Dr. med.  Martin  Siepmann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Institut für Klinische Pharmakologie, Medizinische Fakultät, TU Dresden
    • Mr.  Dr. med.  Timo  Siepmann 
    • Fiedlerstr. 27
    • 01307  Dresden
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Psychotherapie und Psychosomatik , Universitätsklinikum der TU Dresden
    • Mr.  Prof. Dr. med.  Martin  Siepmann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Fachklinik Weinböhla
    • Mr.  Prof. Dr.  Martin  Siepmann 
    • Heidehof 1
    • 01689  Weinböhla
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum der TU Dresden Klinik für Psychotherapie und Psychosomatik
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.