Smoking Cessation Using Motivational Therapy and Varenicline
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ClinicalTrials.gov Identifier: NCT00701896 |
Recruitment Status
:
Completed
First Posted
: June 19, 2008
Last Update Posted
: February 13, 2017
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Sponsor:
Philip Diaz
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
Tracking Information | ||||
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First Submitted Date ICMJE | June 17, 2008 | |||
First Posted Date ICMJE | June 19, 2008 | |||
Last Update Posted Date | February 13, 2017 | |||
Study Start Date ICMJE | June 2008 | |||
Actual Primary Completion Date | April 20, 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 48 Months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00701896 on ClinicalTrials.gov Archive Site | |||
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 | Smoking Cessation Using Motivational Therapy and Varenicline | |||
Official Title ICMJE | Smoking Cessation and the Natural History of HIV-Associated Emphysema | |||
Brief Summary | People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema. | |||
Detailed Description | HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
368 | |||
Original Estimated Enrollment ICMJE |
365 | |||
Actual Study Completion Date | June 20, 2013 | |||
Actual Primary Completion Date | April 20, 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00701896 | |||
Other Study ID Numbers ICMJE | 2007H0173 R01HL090313 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Philip Diaz, The Ohio State University | |||
Study Sponsor ICMJE | Philip Diaz | |||
Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | |||
Investigators ICMJE |
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PRS Account | Ohio State University | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |