Smoking Cessation in Alcoholics

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial

Conditions
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Smoking Cessation, Alcohol Consumption

Intervention / Treatment
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* Behavioral: Cognitive-behavioural smoking cessation program
* Behavioral: Autogenic training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: alcohol-dependent smoker intend to stop or reduce smoking for at least 50% Exclusion Criteria: taking part in another smoking cessation program being pregnant not able to understand instruction due to cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Cognitive-behavioural smoking cessation program | Behavioral: Cognitive-behavioural smoking cessation program<br>* 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.<br>* Other names: Nichtraucher in 6 Wochen (Batra & Buchkremer);|
| Other: Control group<br>Autogenic training | Behavioral: Autogenic training<br>* Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.<br>* Other names: Autogenous Training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking in the Last 7 Days (Patients Report + Urine Sample) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Alcohol, Outcome, Harm reduction, Alcohol drinking, Treatment outcome, Treatment effectiveness