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Brief Interventions on Smoking for Hormonal Contraceptive Users (BRISC)

This study has been completed.
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00726141
First received: July 28, 2008
Last updated: July 30, 2008
Last verified: July 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Brief Interventions on Smoking for Hormonal Contraceptive Users

Resource links provided by NLM:


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:
    Behavioral: Brief intervention, Motivational Interviewing, Expert System
    Motivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter
    Other Name: Brief intervention, Motivational Interviewing, Expert System
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: July 28, 2008
Last Updated: July 30, 2008
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

Additional relevant MeSH terms:
Contraceptive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014