Smoking Cessation in Alcoholics

Smoking Cessation Clinical Trial

Official title:

Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963482
• Other study ID #: BAG - 06.004264
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: March 9, 2015
• Start date: July 2007
• Est. completion date: August 2011

Study information

• Verified date: March 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Smoking Cessation

Intervention

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.
• Autogenic training
Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.

Locations

Country	Name	City	State
Switzerland	Psychiatric Hospital of the University of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months	No
Secondary	Drinking in the Last 7 Days (Patients Report + Urine Sample)		6 months	No