Brief Interventions on Smoking for Hormonal Contraceptive Users - Full Text View

Sponsored by:	University of Luebeck
Information provided by:	University of Luebeck
ClinicalTrials.gov Identifier:	NCT00726141

Purpose

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.

Condition	Intervention
Smoking	Behavioral: Brief intervention, Motivational Interviewing, Expert System

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study
Official Title:	Brief Interventions on Smoking for Hormonal Contraceptive Users

Further study details as provided by University of Luebeck:

Primary Outcome Measures:

Smoking cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of smoking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Readiness to change variables [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Level of nicotine dependence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Quit attempts [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	699
Study Start Date:	October 2004
Study Completion Date:	October 2007
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed 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.

Eligibility

Ages Eligible for Study:	14 Years to 25 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726141

Locations

Germany
University of Lübeck
Lübeck, Germany

Sponsors and Collaborators

University of Luebeck

Investigators

Principal Investigator:

PD Dr. Hans-Jürgen Rumpf, Dipl.-Psych.

University of Lübeck, Germany

More Information

Responsible Party:	University of Lübeck, Research group S:TEP (Substance misuse: Treatment, Epidemiology and Prevention) ( PD Dr. Hans-Jürgen Rumpf )
Study ID Numbers:	01EB0421, BMBF grant no: 01EB0421
Study First Received:	July 28, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00726141
Health Authority:	Germany: Federal Ministry of Education and Research; Germany: Ethics Commission

Keywords provided by University of Luebeck:

Brief Intervention
Smoking Cessation
Motivational Interviewing
Expert System

Readiness to Change
Hormonal Contraceptive
Adolescents

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 14, 2009