Alcohol Consumption, Smoking Cessation
Conditions
Keywords
Smoking, Alcohol, Outcome, Harm reduction, Alcohol drinking, Treatment outcome, Treatment effectiveness
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).
Detailed description
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.
Interventions
BEHAVIORALCognitive-behavioural smoking cessation program
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.
BEHAVIORALAutogenic training
Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Smoke-free Patients | 6 months | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Drinking in the Last 7 Days (Patients Report + Urine Sample) | 6 months |
Countries
Switzerland
Participant flow
Recruitment details
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
Pre-assignment details
Out of 237 screened patients, 103 were enrolled. Intervention group(EG)=53; Control group (CG)=50.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Cognitive-behavioural smoking cessation program | 53 |
| Control Group Autogenic training | 50 |
| Total | 103 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 53 Participants | 103 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 9 | 44 years STANDARD_DEVIATION 11 | 44 years STANDARD_DEVIATION 10 |
| Region of Enrollment Switzerland | 50 participants | 53 participants | 103 participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 36 Participants | 37 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 0 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 50 |
Outcome results
Primary
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)
Time frame: 6 months
Population: Intention-to-treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Smoke-free Patients | 0 participants |
| Control Group | Number of Smoke-free Patients | 3 participants |
Comparison: H0: EG is equal in smoking quit rates compared to CG. H1: EG is superior in smoking quit rates compared to CGp-value: =0.111Chi-squared
Secondary
Drinking in the Last 7 Days (Patients Report + Urine Sample)
Time frame: 6 months