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Brief Interventions on Smoking for Hormonal Contraceptive Users (BRISC)

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ClinicalTrials.gov Identifier: NCT00726141
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : July 31, 2008
Sponsor:
Information provided by:
University of Luebeck

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Brief intervention, Motivational Interviewing, Expert System Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 699 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Brief Interventions on Smoking for Hormonal Contraceptive Users
Study Start Date : October 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Luebeck

Responsible Party: PD Dr. Hans-Jürgen Rumpf, University of Lübeck, Research group S:TEP (Substance misuse: Treatment, Epidemiology and Prevention)
ClinicalTrials.gov Identifier: NCT00726141     History of Changes
Other Study ID Numbers: 01EB0421
BMBF grant no: 01EB0421
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: July 31, 2008
Last Verified: July 2008

Keywords provided by University of Luebeck:
Brief Intervention
Smoking Cessation
Motivational Interviewing
Expert System
Readiness to Change
Hormonal Contraceptive
Adolescents

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs