Trial document





This trial has been registered retrospectively.
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  DRKS00003344

Trial Description

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Title

In-patient smoking cessation tretment in comorbid patients with other substance dependance

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In Germany, in-patient smoking withdrawal is not covered by health insurances. As a consequence, nicotine-dependant patients are only admitted for a withdrawal of another substance. During their stay in clinic they should be motivated to withdraw from their nicotine-dependance as well.
In this study, we assess our current in-patient treatment program for comorbid patients who have a substance dependance and an additional nicotine dependance. All patients are included in the study, either in the continuous smoking arm or in the smoking cessation arm.
The smoking cessation program consists of motivational group therapy program, medical advice and smoking withdrawal medication such as nicotine replacement therapy, bupropione or varenicline. The medication is standard therapy.
Patients are requested to fill out questionaires at admission, 7 days after admission and at discharge and a telefone interview is scheduled 3 months after discharge to evaluate current smoking habits.
We want to evaluate whether our substance dependant patient can be also motivated to withdraw from nicotine in an in-patient setting which lasts 3 weeks and whether smoking cessation can be achieved in this population.

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Brief Summary in Scientific Language

A large number of patients with a substance dependance are also nicotine-dependant. The comorbidity of alcohol dependance and nicotine dependance amounts to 80%. 30% of these patients die before the age of 60 where nicotine dependance primarily accounts for organ damage and death.
Particularly patients with alcohol dependance were considered not to be motivated for nicotine dependance and that a withdrawal of both substances at the same time would be impossible or at least associated with increased levels of relapse. Based upon these assumptions, in-patient smoking cessation treatment was for a long time no standard therapy in patients who were admitted for another substance use disorder.
In Germany, in-patient smoking cessation therapy is further compromized since health insurences only cover for smoking withdrawal therapy in the context of a withdrawal from another substance like alcohol or amphetamine. As a consequence, nicotine dependant patients are admitted for another substance disorder and need to be motivated to withdraw from nicotine as well on admission.
In this study, we assess our current in-patient treatment program for comorbid patients who have a substance dependance and an additional nicotine dependance. All patients are requested to participate in the study, either in the continuous smoking arm or in the smoking cessation arm.
The smoking cessation program consists of a motivational group therapy program, medical advice and smoking withdrawal medication such as nicotine replacement therapy, bupropione or varenicline. The medication is standard therapy.
Patients are requested to fill out general and substance-specific questionaires (FÄR, QSU, BSI,OCDS, SOKRATES-N,WHO-QOL-BREF, ADS, AASE, SCQ-A, FTND, SER-G, ISMI-R, STAI G Form X2, BDI, BIS-11, TCI, PSS)
at admission, 7 days after admission and at discharge and a telefone interview is scheduled 3 months after discharge to evaluate current smoking status.
Based upon the questionaires and clinical interviews, we plan to assess the rate of smoking reduction and of smoking abstinence as well as the rate of abstinence from the other substance. We also want to define subgroups which profit most from therapy.
On a broader scale, we want to investigate whether our current smoking cessation program is reasonable to continue which require substantial numbers of patients willing to attempt smoking cessation within our program but also substantial abstinence rates at discharge and at the catamnesis timepoint.

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Organizational Data

  •   DRKS00003344
  •   2011/12/06
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  •   yes
  •   Approved
  •   2011-220N-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

  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
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Interventions/Observational Groups

  •   smoking cessation therapy with combined psychotherapy and medication:
    Structured clinical interview and questionaires on admission, on day 7, at discharge and 3 months after discharge via a telefone interview
  •   smoking cessation therapy with medication only:
    Structured clinical interview and questionaires on admission, on day 7, at discharge and 3 months after discharge via a telefone interview
  •   smoking cessation therapy with psychotherapy only:
    Structured clinical interview and questionaires on admission, on day 7, at discharge and 3 months after discharge via a telefone interview
  •   no treatmant:
    Structured clinical interview and questionaires on admission, on day 7, at discharge and 3 months after discharge via a telefone interview
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control, No treatment
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

Nicotine abstinence rate 3 months after hospital discharge

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Secondary Outcome

1. Nikotine abstinence at discharge
2. nicotine reduction at discharge compared to admission
3. nicotine reduction 3 months after discharge compared to admission and discharge
4. other substance abstinence 3 months after discharge
5. rate of nicotine dependant patients who could be motivated to attempt smoking cessation during hospital stay.
6. nicotine reduction/abstinence 3 months after discharge: group comparison of varenicline arm, nicotine replacement therapy arm, Bupropione arm, only cognitive psychotherapy arm, no therapy arm
7. subgroup analysis of patient data for identification od patient subgroups profiting most from therapy program.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/03/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

nicotine dependance,
other substance dependance

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Exclusion Criteria

severe cognitive deficitis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Dr. med.   Tillmann  Weber 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Dr. med.  Tillmann  Weber 
    • J 5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Dr. med.  Tillmann  Weber 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Abhängiges Verhalten und Suchtmedizin Zentralinstitut für Seelische Gesundheit Universität Heidelberg
    • 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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