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
  Purpose

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.


Condition Intervention
Smoking
Tobacco Use Cessation
Smoking Cessation
Behavioral: Brief advice
Behavioral: Compact cessation course
Behavioral: Standard cessation course

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Continuous abstinence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Biochemical validation by measurement of urine cotinine levels


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 800
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brief advice
A brief advice to stop smoking of about 10 min accompanied with self-help material
Behavioral: Brief advice
Brief advice of about 10 min accompanied by self-help material
Experimental: Compact cessation course
Cessation intervention of 2 x 120 min in a group setting
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.
Active Comparator: Standard cessation course
Cessation course in a group setting over 6 dates
Behavioral: Standard cessation course
Cessation course over 6 dates. Group setting.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589211

Locations
Germany
Thoraxklinik Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69126
Zentrum für Tabakentwöhnung Stuttgart (ZfT)
Stuttgart, Baden-Württemberg, Germany, 70178
Klinikum der Universität München - Klinik für Psychiatrie und Psychotherapie
Munich, Bavaria, Germany, 80331
Technische Universität Chemnitz - Institut für Psychologie
Chemnitz, Saxony, Germany, 09120
Institut für Raucherberatung und Tabakentwöhnung am Gemeinsschaftskrankenhaus Havelhöhe
Berlin, Germany, 14089
Sponsors and Collaborators
Heidelberg University
Pfizer
Investigators
Principal Investigator: Alexander Rupp, Dr. Heidelberg University
Study Chair: Michael Kreuter, PD Dr. Heidelberg University
Study Director: Felix JF Herth, Prof. Heidelberg University
  More Information

No publications provided

Responsible Party: Felix JF Herth, Dr. med. Alexander Rupp, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01589211     History of Changes
Other Study ID Numbers: WS899101
Study First Received: April 27, 2012
Last Updated: April 30, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
smoking
cessation
intervention
brief

ClinicalTrials.gov processed this record on October 23, 2014