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Smoking Cessation in Alcoholics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00963482
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : April 13, 2012
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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).

Condition or disease Intervention/treatment Phase
Smoking Cessation Alcohol Consumption Behavioral: Cognitive-behavioural smoking cessation program Behavioral: Autogenic training Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial
Study Start Date : July 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Cognitive-behavioural smoking cessation program
 Behavioral: Cognitive-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.
Other Name: Nichtraucher in 6 Wochen (Batra & Buchkremer)
Control group
Autogenic training
 Behavioral: Autogenic training
Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.
Other Name: Autogenous Training


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Drinking in the Last 7 Days (Patients Report + Urine Sample) [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963482


Locations
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Switzerland
Psychiatric Hospital of the University of Basel
Basel, Switzerland, CH-4025
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Gerhard A. Wiesbeck, Prof. Dr. Psychiatric Hospital of the University of Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00963482    
Other Study ID Numbers: BAG - 06.004264
First Posted: August 21, 2009    Key Record Dates
Results First Posted: April 13, 2012
Last Update Posted: March 27, 2015
Last Verified: March 2015
Keywords provided by University Hospital, Basel, Switzerland:
Smoking
Alcohol
Outcome
Harm reduction
 Alcohol drinking
Treatment outcome
Treatment effectiveness
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior