Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking, Tobacco Use Cessation, Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Smoker
- Age > 18 years
- Motivation to quit smoking
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Smoking, Tobacco Use Cessation, Smoking CessationBrief Intervention Study for Quitting Smoking
NCT01589211
- Heidelberg, Baden-Württemberg
- Stuttgart, Baden-Württemberg
- Munich, Bavaria
- Chemnitz, Saxony
- Berlin,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| 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 |
| |||||||||
| Intervention ICMJE |
| |||||||||
| Study Arms ICMJE |
| |||||||||
| 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 | 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:
Exclusion Criteria:
| |||||||||
| Sex/Gender ICMJE |
| |||||||||
| 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 |
| |||||||||
| 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 | ||||||||||