Smoking CessationNCT00963482
Smoking Cessation in Alcoholics
A study testing Cognitive-behavioural smoking cessation program and Autogenic training in people with Smoking Cessation and Alcohol Consumption, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Alcohol Consumption
- What is being tested?
- Cognitive-behavioural smoking cessation program and Autogenic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2007to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- alcohol-dependent
- smoker
- intend to stop or reduce smoking for at least 50%
Who cannot join
- taking part in another smoking cessation program
- being pregnant
- not able to understand instruction due to cognitive impairment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric Hospital of the University of Basel
Basel, CH-4025
About this study
Official title: Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial
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).
Read the 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.
- Conditions
- Smoking Cessation, Alcohol Consumption
- Being tested
- Cognitive-behavioural smoking cessation program, Autogenic training
- Keywords
- Smoking, Alcohol, Outcome, Harm reduction, Alcohol drinking, Treatment outcome, Treatment effectiveness
- Medical subject headings
- Smoking Cessation, Alcohol Drinking, Smoking, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioural smoking cessation programBehavioural
Also called Nichtraucher in 6 Wochen (Batra & Buchkremer)
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.
Autogenic trainingBehavioural
Also called Autogenous Training
Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Cognitive-behavioural smoking cessation program Receives: Behavioral: Cognitive-behavioural smoking cessation program |
| Control group | Other | Autogenic training Receives: Behavioral: Autogenic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
Drinking in the Last 7 Days (Patients Report + Urine Sample)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard A. Wiesbeck, Prof. Dr., Principal investigator, Psychiatric Hospital of the University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963482
- Sponsor's protocol ID
- BAG - 06.004264
- Status last verified
- Mar 2015
- First submitted
- 20 Aug 2009
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00963482
- Acronym / sponsor ID
- BAG - 06.004264
- Conditions
- Smoking Cessation, Alcohol Consumption
- Keywords
- Smoking, Alcohol, Outcome, Harm reduction, Alcohol drinking, Treatment outcome, Treatment effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Posted 13 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cognitive-behavioural smoking cessation programCognitive-behavioural smoking cessation program |
| Control group | Other | Behavioral: Autogenic trainingAutogenic training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- alcohol-dependent
- smoker
- intend to stop or reduce smoking for at least 50%
Key exclusion criteria (3 listed)
- taking part in another smoking cessation program
- being pregnant
- not able to understand instruction due to cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioural smoking cessation programAlso: Nichtraucher in 6 Wochen (Batra & Buchkremer)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. | Behavioural | Intervention group |
| Autogenic trainingAlso: Autogenous TrainingLearning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation. | Behavioural | Control group |
Primary outcome
Number of Smoke-free Patients
Time frame: 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)
1 secondary outcome
Drinking in the Last 7 Days (Patients Report + Urine Sample)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Using Smartwatches to Monitor Smoking in Real-life Situations
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Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard A. Wiesbeck, Prof. Dr. principal investigator
Psychiatric Hospital of the University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioural smoking cessation program and Autogenic training in people with Smoking Cessation and Alcohol Consumption, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Smoke-free Patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.