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Smoking Cessation in Alcoholics

Primary Purpose

Smoking Cessation, Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cognitive-behavioural smoking cessation program
Autogenic training
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking, Alcohol, Outcome, Harm reduction, Alcohol drinking, Treatment outcome, Treatment effectiveness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Hospital of the University of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

Cognitive-behavioural smoking cessation program

Autogenic training

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Drinking in the Last 7 Days (Patients Report + Urine Sample)

Full Information

First Posted
August 20, 2009
Last Updated
March 9, 2015
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00963482
Brief Title
Smoking Cessation in Alcoholics
Official Title
Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Alcohol Consumption
Keywords
Smoking, Alcohol, Outcome, Harm reduction, Alcohol drinking, Treatment outcome, Treatment effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Cognitive-behavioural smoking cessation program
Arm Title
Control group
Arm Type
Other
Arm Description
Autogenic training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioural smoking cessation program
Other Intervention Name(s)
Nichtraucher in 6 Wochen (Batra & Buchkremer)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Autogenic training
Other Intervention Name(s)
Autogenous Training
Intervention Description
Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.
Primary Outcome Measure Information:
Title
Number of Smoke-free Patients
Description
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
Secondary Outcome Measure Information:
Title
Drinking in the Last 7 Days (Patients Report + Urine Sample)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard A. Wiesbeck, Prof. Dr.
Organizational Affiliation
Psychiatric Hospital of the University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Hospital of the University of Basel
City
Basel
ZIP/Postal Code
CH-4025
Country
Switzerland

12. IPD Sharing Statement

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Smoking Cessation in Alcoholics

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