SmokingBRISCNCT00726141
Brief Interventions on Smoking for Hormonal Contraceptive Users
A study testing Brief intervention, Motivational Interviewing, Expert System in people with Smoking, run by University of Luebeck at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 14 to 25 years, women only
- Conditions the study is for
- Smoking
- What is being tested?
- Brief intervention, Motivational Interviewing, Expert System
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 699 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Emergency treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Brief intervention, Motivational Interviewing, Expert System
- Keywords
- Brief Intervention, Smoking Cessation, Motivational Interviewing, Expert System, Readiness to Change, Hormonal Contraceptive, Adolescents
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief intervention, Motivational Interviewing, Expert SystemBehavioural
Motivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Measured: 12 months
Secondary outcomes (4)
Reduction of smoking
Measured: 12 months
Readiness to change variables
Measured: 12 months
Level of nicotine dependence
Measured: 12 months
Quit attempts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startOct 2004
- Primary completionJan 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Investigators
- PD Dr. Hans-Jürgen Rumpf, Dipl.-Psych., Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726141
- Sponsor's protocol ID
- 01EB0421
- Other IDs
- BMBF grant no: 01EB0421
- Acronym
- BRISC
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 31 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Interventions on Smoking for Hormonal Contraceptive Users
- ClinicalTrials.gov ID
- NCT00726141
- Acronym / sponsor ID
- BRISC / 01EB0421
- Conditions
- Smoking
- Keywords
- Brief Intervention, Smoking Cessation, Motivational Interviewing, Expert System, Readiness to Change, Hormonal Contraceptive, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 14 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Emergency treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief intervention, Motivational Interviewing, Expert SystemMotivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter | Behavioural | – |
Primary outcome
Smoking cessation
Time frame: 12 months
4 secondary outcomes
Reduction of smoking
Time frame: 12 months
Readiness to change variables
Time frame: 12 months
Level of nicotine dependence
Time frame: 12 months
Quit attempts
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PD Dr. Hans-Jürgen Rumpf, Dipl.-Psych. principal investigator
University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention, Motivational Interviewing, Expert System in people with Smoking, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2008.