Tobacco SmokingPhase 2NCT00678938
Smoking Interventions in the General Population
A Phase 2 study testing Smoking abstinence oriented expert system intervention and Smoking reduction oriented expert system intervention in people with Tobacco Smoking, run by University Medicine Greifswald.
Trial summary
The study takes up two problems: 1) Little research exists about general population interventions for smokers not ready to quit within the foreseeable future. 2) There is little evidence for smoking reduction as a behavioural goal in interventions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Smoking abstinence oriented expert system intervention and Smoking reduction oriented expert system intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,462 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Oct 2008
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Daily smoking of 10 or more cigarettes
- No intention to quit within the next six month
- Age of 18 years and older
- valid telephone number
Who cannot join
- Insufficient german language and cognitive capabilities to complete the assessment
About this study
Official title: General Population Based Interventions for Smokers Not Ready to Quit: Testing Smoking Reduction vs. Abstinence Oriented Computer Expert Systems
The study takes up two problems: 1) Little research exists about general population interventions for smokers not ready to quit within the foreseeable future. 2) There is little evidence for smoking reduction as a behavioural goal in interventions. Interventions based on the Transtheoretical Model of Behavior Change (TTM) using computer expert-system technology yield delayed and smaller effects in smokers in the precontemplation stage of change compared to smokers in more advanced stages of change. Reducing the number of cigarettes smoked per day is currently discussed as an intermediate goal for this subgroup. Epidemiological and clinical studies revealed that smokers are able to maintain a substantial reduction. No undermining effects with respect to smoking cessation have been found. However, there are no studies that test the efficacy of behavioural interventions for smoking reduction using population based recruitment. Objectives: Testing the efficacy of TTM based interventions for general population smokers not intending to quit smoking, i.e. a smoking-reduction and a smoking-cessation tailored intervention using computerized expert-system technology.
- Conditions
- Tobacco Smoking
- Being tested
- Smoking abstinence oriented expert system intervention, Smoking reduction oriented expert system intervention
- Keywords
- smoking reduction, smoking cessation, stages of change, expert system interventions
- Medical subject headings
- Tobacco Smoking, Smoking Reduction, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking abstinence oriented expert system interventionBehavioural
Participants received up to three counselling letters targeting smoking cessation
Smoking reduction oriented expert system interventionBehavioural
Participants received up to three counselling letters targeting smoking reduction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Smoking abstinence oriented expert system intervention |
| 2 | Experimental | Not described Receives: Behavioral: Smoking reduction oriented expert system intervention |
| 3 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence of tobacco abstinence
Measured: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments
Secondary outcomes (3)
number of Cigarettes smoked per day
Measured: 4 weeks preceeding follow-up assessment
number of quit and cutdown attempts
Measured: last 12 months preceeding follow-up assessment
Stages of change progress
Measured: at 12 and 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startOct 2004
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,462 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Christian Meyer, Dr., Principal investigator, Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social MedicineUlrich John, Prof. Dr., Study director, Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678938
- Sponsor's protocol ID
- E2_P5, 01EB0420
- Status last verified
- May 2008
- First submitted
- 14 May 2008
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Population Based Interventions for Smokers Not Ready to Quit: Testing Smoking Reduction vs. Abstinence Oriented Computer Expert Systems
- ClinicalTrials.gov ID
- NCT00678938
- Acronym / sponsor ID
- E2_P5, 01EB0420
- Conditions
- Tobacco Smoking
- Keywords
- smoking reduction, smoking cessation, stages of change, expert system interventions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,462 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 16 May 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.
The study takes up two problems: 1) Little research exists about general population interventions for smokers not ready to quit within the foreseeable future. 2) There is little evidence for smoking reduction as a behavioural goal in interventions. Interventions based on the Transtheoretical Model of Behavior Change (TTM) using computer expert-system technology yield delayed and smaller effects in smokers in the precontemplation stage of change compared to smokers in more advanced stages of change. Reducing the number of cigarettes smoked per day is currently discussed as an intermediate goal for this subgroup. Epidemiological and clinical studies revealed that smokers are able to maintain a substantial reduction. No undermining effects with respect to smoking cessation have been found. However, there are no studies that test the efficacy of behavioural interventions for smoking reduction using population based recruitment. Objectives: Testing the efficacy of TTM based interventions for general population smokers not intending to quit smoking, i.e. a smoking-reduction and a smoking-cessation tailored intervention using computerized expert-system technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Smoking abstinence oriented expert system intervention |
| 2 | Experimental | Behavioral: Smoking reduction oriented expert system intervention |
| 3 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Daily smoking of 10 or more cigarettes
- No intention to quit within the next six month
- Age of 18 years and older
- valid telephone number
Key exclusion criteria (1 listed)
- Insufficient german language and cognitive capabilities to complete the assessment
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 |
|---|---|---|
| Smoking abstinence oriented expert system interventionParticipants received up to three counselling letters targeting smoking cessation | Behavioural | 1 |
| Smoking reduction oriented expert system interventionParticipants received up to three counselling letters targeting smoking reduction | Behavioural | 2 |
Primary outcome
Point prevalence of tobacco abstinence
Time frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments
3 secondary outcomes
number of Cigarettes smoked per day
Time frame: 4 weeks preceeding follow-up assessment
number of quit and cutdown attempts
Time frame: last 12 months preceeding follow-up assessment
Stages of change progress
Time frame: at 12 and 24 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
Christian Meyer, Dr. principal investigator
Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine
Ulrich John, Prof. Dr. study director
Ernst-Moritz-Arndt-University of Greifswald, Institute of Epidemiology and Social Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Smoking abstinence oriented expert system intervention and Smoking reduction oriented expert system intervention in people with Tobacco Smoking, run by University Medicine Greifswald.
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 4 inclusion and 1 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 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Point prevalence of tobacco abstinence (time frame: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 and 24 month follow-up assessments). 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 16 May 2008; AzTrials last refreshed its copy on 29 Oct 2026.