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Trial record 1 of 1 for:    NCT01589211
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Brief Intervention Study for Quitting Smoking (BISQUITS)

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ClinicalTrials.gov Identifier: NCT01589211
Recruitment Status : Unknown
Verified April 2012 by Felix JF Herth, Heidelberg University.
Recruitment status was:  Enrolling by invitation
First Posted : May 1, 2012
Last Update Posted : May 1, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Felix JF Herth, Heidelberg University

Tracking Information
First Submitted Date  ICMJE April 27, 2012
First Posted Date  ICMJE May 1, 2012
Last Update Posted Date May 1, 2012
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2012)
Continuous abstinence rate [ Time Frame: 12 months ]
Biochemical validation by measurement of urine cotinine levels
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2012)
  • Continuous abstinence rate [ Time Frame: 6 months ]
  • Time point abstinence rate [ Time Frame: 6 and 12 months ]
  • Quality of life [ Time Frame: 0, 6 and 12 months ]
  • Depression [ Time Frame: 0, 6 and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Intervention Study for Quitting Smoking
Official Title  ICMJE Not Provided
Brief Summary To investigate the effectiveness of a smoking cessation intervention of two sessions (120 min at a time) in a group setting on the basis of Motivational Interviewing (MI) and important elements of Cognitive Behavioural Therapy (CBT). According to national and international guidelines patients are advised to quit and pharmacologically supported with one of the established first line smoking cessation treatments.
Detailed Description The study design is multicentric, prospective, randomized and controlled. The study is taking place in cooperation with smoking clinics of 5 centres in Germany (Heidelberg, Stuttgart, Munich, Chemnitz, Berlin). A total number of 800 smokers is calculated to participate in the study. After enrollment participants are randomized in one of the three intervention groups: (A) "Advice only", (B) "Brief intervention", (C) "Intensive therapy". The follow up includes a telephone interview 3 months after the last intervention, and two visits at the smoking clinics after 6 and 12 months with biochemical validation of the smoking status by measurement of the exhaled carbon monoxide and the concentration of cotinine in an urine sample respectively. The primary endpoint is the continuous abstinence rate after 12 months. Several secondary endpoints are determined amongst others the continuous abstinence rate after 6 months, point prevalence cessation rates after 6 and 12 months, life quality, weight gain, predictors of a successful cessation attempt.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Smoking
  • Tobacco Use Cessation
  • Smoking Cessation
Intervention  ICMJE
  • Behavioral: Brief advice
    Brief advice of about 10 min accompanied by self-help material
  • Behavioral: Compact cessation course
    Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.
  • Behavioral: Standard cessation course
    Cessation course over 6 dates. Group setting.
Study Arms  ICMJE
  • Active Comparator: Brief advice
    A brief advice to stop smoking of about 10 min accompanied with self-help material
    Intervention: Behavioral: Brief advice
  • Experimental: Compact cessation course
    Cessation intervention of 2 x 120 min in a group setting
    Intervention: Behavioral: Compact cessation course
  • Active Comparator: Standard cessation course
    Cessation course in a group setting over 6 dates
    Intervention: Behavioral: Standard cessation course
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2012)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Smoker
  • Age > 18 years
  • Motivation to quit smoking

Exclusion Criteria:

  • severe somatic comorbidity or reduced life expectancy
  • severe episode of a psychiatric disease
  • reduced cognitive ability
  • abuse of alcohol or illicit drugs
  • other reasons at the discretion of responsible local study tutor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01589211
Other Study ID Numbers  ICMJE WS899101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felix JF Herth, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Alexander Rupp, Dr. Heidelberg University
Study Chair: Michael Kreuter, PD Dr. Heidelberg University
Study Director: Felix JF Herth, Prof. Heidelberg University
PRS Account Heidelberg University
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP