Smoking Cessation in Alcoholics
Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial
1 other identifier
interventional
103
1 country
1
Brief Summary
Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate whether a specific smoking cessation program (based on cognitive-behavioral therapy) for inpatient alcohol-dependent smokers is more effective than a control condition (treatment as usual).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
April 13, 2012
CompletedMarch 27, 2015
March 1, 2015
2.5 years
August 20, 2009
February 1, 2012
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Smoke-free Patients
Smoke-free defined with following measures: * patients self-report about smoking in the last 7 days (yes/no) * CO-level (smoke-free \<10ppm) * urine sample (cotinine)
6 months
Secondary Outcomes (1)
Drinking in the Last 7 Days (Patients Report + Urine Sample)
6 months
Study Arms (2)
Intervention group
EXPERIMENTALCognitive-behavioural smoking cessation program
Control group
OTHERAutogenic training
Interventions
It's a cognitive-behavioural intervention for smoking cessation. Originally based on a 6 week program designed for outpatients (Batra \& Buchkremer 2004). This program was then specifically tailored for inpatient use with additional information addressing the interaction of smoking and drinking and its consequences.
Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.
Eligibility Criteria
You may qualify if:
- alcohol-dependent
- smoker
- intend to stop or reduce smoking for at least 50%
You may not qualify if:
- taking part in another smoking cessation program
- being pregnant
- not able to understand instruction due to cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatric Hospital of the University of Basel
Basel, CH-4025, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Originally two recruiting centers were planned, what failed. Though less subjects than expected.
Results Point of Contact
- Title
- M. Sc. S. Müller (Site-investigator) Prof. G. A. Wiesbeck (PI)
- Organization
- Divsion Substance Use Disorder, Psychiatric Hospital of the Univeristy of Basel
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard A. Wiesbeck, Prof. Dr.
Psychiatric Hospital of the University of Basel
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 21, 2009
Study Start
July 1, 2007
Primary Completion
January 1, 2010
Study Completion
August 1, 2011
Last Updated
March 27, 2015
Results First Posted
April 13, 2012
Record last verified: 2015-03