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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 27, 2012

Last Updated Date

April 30, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Continuous abstinence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biochemical validation by measurement of urine cotinine levels

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01589211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrolling by invitation

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01589211

Other Study ID Numbers ^ICMJE

WS899101

Has Data Monitoring Committee

Responsible Party

Felix JF Herth, University of Heidelberg

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Principal Investigator:	Alexander Rupp, Dr.	University of Heidelberg
Study Chair:	Michael Kreuter, PD Dr.	University of Heidelberg
Study Director:	Felix JF Herth, Prof.	University of Heidelberg

Information Provided By

University of Heidelberg

Verification Date

April 2012

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

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