A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 12, 2011 | ||||
| Last Updated Date | April 12, 2011 | ||||
| Start Date ICMJE | April 2011 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Biologically confirmed tobacco cessation [ Time Frame: 6 months ] [ Designated as safety issue: No ] The primary outcome will be validated tobacco cessation at 6 months. Biologically confirmed tobacco cessation will be assessed by self-report of smoking status combined with CO measurement. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users | ||||
| Official Title ICMJE | A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users | ||||
| Brief Summary | Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases. Quitting smoking is proven to improve the health of people addicted to cigarettes. . Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking. Additionally, most programs designed to help people quit smoking are not very successful. One reason these programs may not work well is because it is difficult to motivate people to quit smoking. New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results. For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old". In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking. The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Tobacco Dependence | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01334736 | ||||
| Other Study ID Numbers ICMJE | TD-10-002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Michael Bradley Drummond, MD MHS, Johns Hopkins University | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | American Thoracic Society | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Johns Hopkins University | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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