Smoking CessationNCT01417793
Effects of a Smoking Cessation Program for Prison Inmates
A study testing Smoking Cessation Program in people with Smoking Cessation, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
According to WHO database, an average of 540 million people worldwide dies from smoking related diseases every year. The use of tobacco products may reduce the average life expectancy of about 15 years. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking Cessation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Jul 2012
- 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prison inmates with age equal or more than 20 years old and have smoked for equal or more than one year
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Prison,Agency of Corrections, Ministry of Justice
Taichung, Taiwan, 40852
Yulung Chen, 886-4-23814169
About this study
Official title: Effects of a Smoking Cessation Program for Prison Inmates-A Case Study of a Prison in Central Taiwan
According to WHO database, an average of 540 million people worldwide dies from smoking related diseases every year. The use of tobacco products may reduce the average life expectancy of about 15 years. The data of 2009 from Department of Health Bureau of Health showed 38.57% male adults and 4.75% female adults smoked in Taiwan. Studies about smoking rate within prison inmates were between 64-91.8%, which was over 3 times than the general population. Smoking cessation can lower the risks of smoking related health problems. Two thirds of smokers in Taiwan once tried smoking cessation but the success rate was about 5% every year.
In view of high smoking rate within prison inmates in Taiwan, Agency of Correction, Ministry of Justice announced a smoking cessation program for inmates in April 2010. The purpose of this study was to investigate the effects of this program and the difference of cessation success rate between various interventional methods, using questionnaires for smokers and smoking cessation clinics database.
- Conditions
- Smoking Cessation
- Being tested
- Smoking Cessation Program
- Keywords
- Smoking cessation rate
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation ProgramBehavioural
Comparison of smoking cessation rate among different smoking cessation program
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation Program | Experimental | Not described Receives: Behavioral: Smoking Cessation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation Rate
Measured: 6 months after each subject's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yulung Chen, M.D, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417793
- Sponsor's protocol ID
- DMR100-IRB-129
- Status last verified
- Aug 2011
- First submitted
- 14 Aug 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Smoking Cessation Program for Prison Inmates-A Case Study of a Prison in Central Taiwan
- ClinicalTrials.gov ID
- NCT01417793
- Acronym / sponsor ID
- DMR100-IRB-129
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 16 Aug 2011 (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.
According to WHO database, an average of 540 million people worldwide dies from smoking related diseases every year. The use of tobacco products may reduce the average life expectancy of about 15 years. The data of 2009 from Department of Health Bureau of Health showed 38.57% male adults and 4.75% female adults smoked in Taiwan. Studies about smoking rate within prison inmates were between 64-91.8%, which was over 3 times than the general population. Smoking cessation can lower the risks of smoking related health problems. Two thirds of smokers in Taiwan once tried smoking cessation but the success rate was about 5% every year.
In view of high smoking rate within prison inmates in Taiwan, Agency of Correction, Ministry of Justice announced a smoking cessation program for inmates in April 2010. The purpose of this study was to investigate the effects of this program and the difference of cessation success rate between various interventional methods, using questionnaires for smokers and smoking cessation clinics database.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Program | Experimental | Behavioral: Smoking Cessation Program |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prison inmates with age equal or more than 20 years old and have smoked for equal or more than one year
Key exclusion criteria (0 listed)
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 Cessation ProgramComparison of smoking cessation rate among different smoking cessation program | Behavioural | Smoking Cessation Program |
Primary outcome
Smoking Cessation Rate
Time frame: 6 months after each subject's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
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.
Yulung Chen, M.D principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Program in people with Smoking Cessation, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 0 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 Aug 2011. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation Rate (time frame: 6 months after each subject's enrollment). 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 Aug 2011.