Smoking Interventions in the General Population

Tobacco Smoking Clinical Trial

Official title:

General Population Based Interventions for Smokers Not Ready to Quit: Testing Smoking Reduction vs. Abstinence Oriented Computer Expert Systems

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00678938
• Other study ID #: E2_P5, 01EB0420
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: May 14, 2008
• Start date: October 2004
• Est. completion date: October 2008

Study information

• Verified date: May 2008
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal German Ministry of Education and Research
• Study type: Interventional

Clinical Trial Summary

The study takes up two problems: 1) Little research exists about general population interventions for smokers not ready to quit within the foreseeable future. 2) There is little evidence for smoking reduction as a behavioural goal in interventions. Interventions based on the Transtheoretical Model of Behavior Change (TTM) using computer expert-system technology yield delayed and smaller effects in smokers in the precontemplation stage of change compared to smokers in more advanced stages of change. Reducing the number of cigarettes smoked per day is currently discussed as an intermediate goal for this subgroup. Epidemiological and clinical studies revealed that smokers are able to maintain a substantial reduction. No undermining effects with respect to smoking cessation have been found. However, there are no studies that test the efficacy of behavioural interventions for smoking reduction using population based recruitment. Objectives: Testing the efficacy of TTM based interventions for general population smokers not intending to quit smoking, i.e. a smoking-reduction and a smoking-cessation tailored intervention using computerized expert-system technology.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1462
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Daily smoking of 10 or more cigarettes

• No intention to quit within the next six month

• Age of 18 years and older

• valid telephone number

Exclusion Criteria:

• Insufficient german language and cognitive capabilities to complete the assessment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• Smoking abstinence oriented expert system intervention
Participants received up to three counselling letters targeting smoking cessation
• Smoking reduction oriented expert system intervention
Participants received up to three counselling letters targeting smoking reduction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence of tobacco abstinence		24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments	No
Secondary	number of Cigarettes smoked per day		4 weeks preceeding follow-up assessment	No
Secondary	number of quit and cutdown attempts		last 12 months preceeding follow-up assessment	No
Secondary	Stages of change progress		at 12 and 24 months follow-up	No