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OpenTrials
Completed

NCT Number: NCT00726141

Brief Interventions on Smoking for Hormonal Contraceptive Users

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

14 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Lübeck

Lübeck, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief intervention, Motivational Interviewing, Expert System

Behavioral

Motivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter

Primary outcomes

  1. Smoking cessation

    Time frame: 12 months

Secondary outcomes

  1. Reduction of smoking

    Time frame: 12 months

  2. Readiness to change variables

    Time frame: 12 months

  3. Level of nicotine dependence

    Time frame: 12 months

  4. Quit attempts

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Acronym: BRISC

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Jul 31, 2008
Registry last updated
Jul 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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