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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Drinking Behavior

ClinicalTrials.gov processed this record on October 23, 2014