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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).
The study is designed as a randomised, controlled trial conducted in an inpatient alcohol treatment institution. Shortly after alcohol detoxification, smokers are offered to voluntarily participate in a smoking cessation program. Participation is possible if patients either want to stop smoking or to reduce their consumption for at least 50%. Patients are asked about their smoking behaviour at the following time points: at admission (T0), after finishing the smoking cessation program or the control condition (T1), one month later by phone (T2) and six months later in a closing meeting (T3). Urine samples and CO-breath controls are taken to check both nicotine and alcohol abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Cognitive-behavioural smoking cessation program |
|
| Control group | Other | Autogenic training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioural smoking cessation program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Smoke-free Patients | Smoke-free defined with following measures:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Drinking in the Last 7 Days (Patients Report + Urine Sample) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard A. Wiesbeck, Prof. Dr. | Psychiatric Hospital of the University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Hospital of the University of Basel | Basel | CH-4025 | Switzerland |
Out of 237 screened patients, 103 were enrolled. Intervention group(EG)=53; Control group (CG)=50.
01.07.2007-31.01.2010 Recruiting process 31.01.2010-31.07.2011 last follow-up sessions location of recruiting: alcohol detoxification unit follow-up: outpatient
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Cognitive-behavioural smoking cessation program |
| FG001 | Control Group | Autogenic training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Cognitive-behavioural smoking cessation program |
| BG001 | Control Group | Autogenic training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Smoke-free Patients | Smoke-free defined with following measures:
| Intention-to-treat analysis | Posted | Number | participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Cognitive-behavioural smoking cessation program |
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Originally two recruiting centers were planned, what failed. Though less subjects than expected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Sc. S. Müller (Site-investigator) Prof. G. A. Wiesbeck (PI) | Divsion Substance Use Disorder, Psychiatric Hospital of the Univeristy of Basel | +41 61 325 53 33 | sandra.mueller@upkbs.ch |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000428 | Alcohol Drinking |
| D012907 | Smoking |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
|
| Autogenic training | Behavioral | Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation. |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Drinking in the Last 7 Days (Patients Report + Urine Sample) | Not Posted | 6 months |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Control Group | Autogenic training | 0 | 50 | 0 | 50 |
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| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |