Brief Intervention Study for Quitting Smoking (BISQUITS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Felix JF Herth, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01589211
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012

April 27, 2012
April 30, 2012
December 2011
November 2012   (final data collection date for primary outcome measure)
Continuous abstinence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biochemical validation by measurement of urine cotinine levels
Same as current
Complete list of historical versions of study NCT01589211 on ClinicalTrials.gov Archive Site
  • Continuous abstinence rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time point abstinence rate [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Brief Intervention Study for Quitting Smoking
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Smoking
  • Tobacco Use Cessation
  • Smoking Cessation
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
800
December 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01589211
WS899101
No
Felix JF Herth, University of Heidelberg
Heidelberg University
Pfizer
Principal Investigator: Alexander Rupp, Dr. Heidelberg University
Study Chair: Michael Kreuter, PD Dr. Heidelberg University
Study Director: Felix JF Herth, Prof. Heidelberg University
Heidelberg University
April 2012

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