Brief Interventions on Smoking for Hormonal Contraceptive Users

Smoking Clinical Trial

— BRISC  

Official title:

Brief Interventions on Smoking for Hormonal Contraceptive Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726141
• Other study ID #: 01EB0421
• Secondary ID: BMBF grant no: 0
• Status: Completed
• Phase: N/A
• First received: July 28, 2008
• Last updated: July 30, 2008
• Start date: October 2004
• Est. completion date: October 2007

Study information

• Verified date: July 2008
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and ResearchGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Despite rising smoker rates, particularly in girls and young women, only few studies have focused on smoking cessation in young smokers. Gynaecologist practices may be an ideal setting to proactively intervene with young female smokers. Elevated health risks of smoking while using hormonal contraceptives could be a successful approach to gain young women's attention on smoking cessation. The purpose of this study is to evaluate the effectiveness of a smoking cessation intervention for girls and young women visiting gynaecologist practices and using hormonal contraceptives.

Description:

In the randomized controlled trial, female smokers aged 14-25 will be recruited in practices of gynaecologists. Intervention within the practice consists of a 30 minutes counseling session based on Motivational Interviewing, a standardised physician letter focusing on the elevated health risks of smoking while using hormonal contraceptives and a stage-matched self-help manual. After four weeks, an expert system feedback letter will be sent. In the intervention group, no smoking intervention will be given. Follow-up assessments will be conducted after 12 months, including saliva cotinine measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: October 2007
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 25 Years

Eligibility

Inclusion Criteria

• Age 14-25

• Having smoked at least 1 cigarette within last 4 weeks

• Use of hormonal contraceptives or intention for prescription within next 2 weeks

Exclusion Criteria:

• Pregnancy

• Emergency treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Brief intervention, Motivational Interviewing, Expert System
Motivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter

Locations

Country	Name	City	State
Germany	University of Lübeck	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation		12 months	No
Secondary	Reduction of smoking		12 months	No
Secondary	Readiness to change variables		12 months	No
Secondary	Level of nicotine dependence		12 months	No
Secondary	Quit attempts		12 months	No