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Smoking Cessation in Alcoholics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00963482
First received: August 20, 2009
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Smoking Cessation
Alcohol Consumption
 Behavioral: Cognitive-behavioural smoking cessation program
Behavioral: Autogenic training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Number of Smoke-free Patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • Drinking in the Last 7 Days (Patients Report + Urine Sample) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: July 2007
Study Completion Date: August 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
No Intervention: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963482

Locations
Switzerland
Psychiatric Hospital of the University of Basel
Basel, Switzerland, CH-4025
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Gerhard A. Wiesbeck, Prof. Dr. Psychiatric Hospital of the University of Basel
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00963482     History of Changes
Other Study ID Numbers: BAG - 06.004264
Study First Received: August 20, 2009
Results First Received: February 1, 2012
Last Updated: March 19, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Smoking
Alcohol
Outcome
Harm reduction
 Alcohol drinking
Treatment outcome
Treatment effectiveness

Additional relevant MeSH terms:
Alcohol Drinking
Smoking
Drinking Behavior
Habits

ClinicalTrials.gov processed this record on May 16, 2013