Smoking CessationNCT00125905
ISTAPS: A Stepped Primary Care Smoking Cessation Intervention
A study testing Advice, Motivational Interviewing and Nicotine Gum and Patch in people with Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Advice, Motivational Interviewing and Nicotine Gum and Patch
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,012 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2003to Jul 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Smokers
- Accept participation and follow-up by phone interviews for 2 years
Who cannot join
- Terminal illness
- Active addictive behaviours or important health problems
Trial locations and contacts
1 site in 1 country.
Spain1 site
Jordi Gol i Gurina Foundation-Primary Care Research Institute
Barcelona, Barcelona, 08007
About this study
Official title: Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)
Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. In addition to that, there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence, especially including motivational interviewing in those not interested in cessation in the very next weeks. This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage he/she is in at the moment, his/her degree of dependence and his/her own characteristics.
Read the detailed description
OBJECTIVES:
- To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers.
- To assess the health status change in relationship with the smoking cessation process.
DESIGN: Cluster randomized clinical trial
Unit of Randomization: Care basic unit (family physician or nurse that cares for the same group of patients). Intention to treat analysis.
PARTICIPANTS: 2911 smokers (ages 14-75 years) consulting for any reason to primary care centers
INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline that includes motivational consulting for smokers at the precontemplation - contemplation stage; brief intervention for smokers in preparation-action who do not want help; intensive intervention with pharmacotherapies for smokers in preparation-action who want help; and reinforcing intervention in the maintenance stage.
CONTROL: Usual care
MEASUREMENT: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process; Health status measured by SF-36.
- Conditions
- Smoking Cessation
- Being tested
- Advice, Motivational Interviewing, Nicotine Gum and Patch, Bupropion
- Keywords
- Primary Care, Smoking Cessation, Stages of Change Model, Health Education, Clinical Practice guideline
- Medical subject headings
- Smoking Cessation, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdviceBehavioural
Motivational InterviewingBehavioural
Nicotine Gum and PatchDrug
BupropionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention
Continuous abstinence rate for 1 year
Change of stage in the smoking cessation process
Secondary outcomes (1)
Health status measured by SF-36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startOct 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,012 participants
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Investigators
- Carmen Cabezas-Peña, MD, Principal investigator, Jordi Gol I Gurina Foundation-ICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125905
- Sponsor's protocol ID
- PI021471
- Other IDs
- PI021471, G03/170
- Status last verified
- Nov 2003
- First submitted
- 1 Aug 2005
- Last updated
- 30 Sep 2009
- Results posted
- No
Publications
Puente D, Cabezas C, Rodriguez-Blanco T, Fernandez-Alonso C, Cebrian T, Torrecilla M, Clemente L, Martin C; ISTAPS study group investigators. The role of gender in a smoking cessation intervention: a cluster randomized clinical trial. BMC Public Health. 2011 May 23;11:369. doi: 10.1186/1471-2458-11-369.
PubMed 21605389Cabezas C, Advani M, Puente D, Rodriguez-Blanco T, Martin C; ISTAPS Study Group. Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study). Addiction. 2011 Sep;106(9):1696-706. doi: 10.1111/j.1360-0443.2011.03491.x. Epub 2011 Jul 22.
PubMed 21561497
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Stepped Primary Care Smoking Cessation Intervention Based on an Evidence Based Clinical Practice Guideline (ISTAPS Project)
- ClinicalTrials.gov ID
- NCT00125905
- Acronym / sponsor ID
- PI021471
- Conditions
- Smoking Cessation
- Keywords
- Primary Care, Smoking Cessation, Stages of Change Model, Health Education, Clinical Practice guideline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,012 participants
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Study start
- Oct 2003
- Study completion
- Jul 2006
- First posted
- 2 Aug 2005 (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.
Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. In addition to that, there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence, especially including motivational interviewing in those not interested in cessation in the very next weeks. This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage he/she is in at the moment, his/her degree of dependence and his/her own characteristics.
Detailed description
OBJECTIVES:
- To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers.
- To assess the health status change in relationship with the smoking cessation process.
DESIGN: Cluster randomized clinical trial
Unit of Randomization: Care basic unit (family physician or nurse that cares for the same group of patients). Intention to treat analysis.
PARTICIPANTS: 2911 smokers (ages 14-75 years) consulting for any reason to primary care centers
INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline that includes motivational consulting for smokers at the precontemplation - contemplation stage; brief intervention for smokers in preparation-action who do not want help; intensive intervention with pharmacotherapies for smokers in preparation-action who want help; and reinforcing intervention in the maintenance stage.
CONTROL: Usual care
MEASUREMENT: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process; Health status measured by SF-36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Smokers
- Accept participation and follow-up by phone interviews for 2 years
Key exclusion criteria (2 listed)
- Terminal illness
- Active addictive behaviours or important health problems
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 |
|---|---|---|
| Advice | Behavioural | – |
| Motivational Interviewing | Behavioural | – |
| Nicotine Gum and Patch | Drug | – |
| Bupropion | Drug | – |
Primary outcome
Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less
Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention
Continuous abstinence rate for 1 year
Change of stage in the smoking cessation process
1 secondary outcome
Health status measured by SF-36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
- Derived from this study: PubMed 21605389Puente D, Cabezas C, Rodriguez-Blanco T, Fernandez-Alonso C, Cebrian T, Torrecilla M, Clemente L, Martin C; ISTAPS study group investigators. The role of gender in a smoking cessation intervention: a cluster randomized clinical trial. BMC Public Health. 2011 May 23;11:369. doi: 10.1186/1471-2458-11-369.
- Derived from this study: PubMed 21561497Cabezas C, Advani M, Puente D, Rodriguez-Blanco T, Martin C; ISTAPS Study Group. Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study). Addiction. 2011 Sep;106(9):1696-706. doi: 10.1111/j.1360-0443.2011.03491.x. Epub 2011 Jul 22.
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
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.
Carmen Cabezas-Peña, MD principal investigator
Jordi Gol I Gurina Foundation-ICS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice, Motivational Interviewing and Nicotine Gum and Patch in people with Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Sep 2009. 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 Spain. 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?
Results are not available in the source record.
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?
Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125905, which also lists 2 linked publications.
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 30 Sep 2009; AzTrials last refreshed its copy on 31 Oct 2026.