Mental attitude of patients and therapists towards the pharmaceutical therapy of alcohol dependence

Organizational Data

DRKS-ID:
DRKS00013881
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2018-04-26
Last update in DRKS:
2020-01-07
Registration type:
Prospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

Aim of this study is to identify factors on behalf of alcohol dependent patients and addiction-therapists inhibiting recommendation, administration and usage of Anti-Craving drugs despite their proven efficacy and recommendation by alcohol-use disorder guidelines by using questionnaire-based clinical interviewing.

Brief summary in scientific language

Aim of this study is to identify factors on behalf of alcohol dependent patients and addiction-therapists inhibiting recommendation, administration and usage (i.e. implementation) of Anti-Craving drugs despite their proven efficacy and recommendation by alcohol-use disorder guidelines by using questionnaire-based systemical clinical interviewing on patients and a questionnaire-based survey on therapists.

Health condition or problem studied

ICD10:
F10.2
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Aim of this study is to identify factors on behalf of 300 alcohol dependent patients (ICD10 F10.2) and addiction-therapists inhibiting recommendation, administration and usage (i.e. implementation) of Anti-Craving drugs despite their proven efficacy and recommendation by alcohol-use disorder guidelines by using questionnaire-based systemical clinical interviewing on patients and a questionnaire-based survey on therapists. Estimated time-range for questioning are 6 months.

Endpoints

Primary outcome:
Primary Aim: To identify factors on behalf of alcohol dependent patients and addiction-therapists inhibiting recommendation, administration and usage of Anti-Craving drugs. Patient questionning: Personal systemic clinical interview of out- and inpatient alcohol-dependant patients. The patient´s questionnaire includes questions on sociodemographic data, somatic and psychiatric illness, substance abuse and addiction, current medication and knowledge on and experience with Anti-Craving drugs. Therapist questionning: The therapist´s questionnaire includes questions on sociodemographic data, work experience in the therapy of substance dependence, knowledge of Anti-Craving drugs and their attitude towards these substances. Answers to the questionnaire are recorded qualitativley and quantitatvely. The patients´questioning is planned to start in July 2018, the therapists´questioning in September 2018
Secondary outcome:
/

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center LVR-Klinik Bonn
  • Medical center LVR-Klinikum Essen Essen

Recruitment period and number of participants

Planned study start date:
2018-06-01
Actual study start date:
2018-06-15
Planned study completion date:
No Entry
Actual Study Completion Date:
2019-03-25
Target Sample Size:
300
Final Sample Size:
351

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Existing alcohol-dependency (ICD10 F10.2), no acute episode of psychotic disorder or intoxication, minimum age of 18 years, sufficient comprehension of the German language in order to fully understand questions asked.

Exclusion Criteria

No existing alcohol-dependency (ICD10: F10.2), acute episode of psychotic disorder, intoxication, younger than 18 years, insufficient comprehension of the German language hence not capable of fully understanding questions asked.

Addresses

Primary Sponsor

Address:
LVR-Klinikum Essen
Prof. Dr. Norbert Scherbaum
Virchowstraße 174
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
LVR-Klinik Bonn
Julian Wellensiek
Kaiser-Karl-Ring 20
53111 Bonn
Germany
Telephone:
02285517355
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Address:
LVR-Klinik Bonn
Julian Wellensiek
Kaiser-Karl-Ring 20
53111 Bonn
Germany
Telephone:
02285517355
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Principal Investigator

Address:
LVR-Klinik Bonn
Julian Wellensiek
Kaiser-Karl-Ring 20
53111 Bonn
Germany
Telephone:
02285517355
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Address:
LVR-Klinikum Essen, Kliniken und Institut der Universität Duisburg-Essen, Klinik für Abhängiges Verhalten und Suchtmedizin
Virchowstraße 174
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
Robert-Koch-Str. 9-11
45147 Essen
Germany
Telephone:
+49-201-7233637
Fax:
+49-201-7235837
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2018-01-19
Ethics committee number:
18-7966-BO
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-04-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry