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Last Updated: May 28, 2022

CLINICAL TRIALS PROFILE FOR NICOTINE POLACRILEX


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All Clinical Trials for Nicotine Polacrilex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00468234 ↗ Validation of Biomarkers of Exposure and Host Response Completed Institute for Science and Health N/A 2005-12-01 The proposed study will evaluate biomarkers measured in exhaled breath condensate (EBC) for the purpose of assessing clinical strategies of harm reduction. It will take advantage of a recently developed device that permits collection of exhaled breath condensate reproducibly, with minimal subject effort and with no oral contamination. The major goal of the trial is to provide evidence to validate biomarkers in EBC. This will be accomplished by collecting samples from asymptomatic smokers before and after inducing a change in their smoking habit (cessation or reduction) with the aid of partial nicotine replacement. Measures to be made in EBC include H2O2, the most widely explored biomarker in this "body" fluid. Methods that reliably can quantify levels in normal non-smokers and in asymptomatic smokers will be used. Two fold increases in smokers have been reported by in several reports and confirmed in preliminary data by the investigators. In addition, other biomarkers of oxidant stress: TBARs, 8-isoprostane and nitrotyrosine will be quantified using standard methods. Biomarkers quantified in EBC will be assessed for reliability (i.e. reproducibility and for sensitivity) to change and for validity (by comparison to clinically defined endpoints and previously validated measures of exposure). Reproducibility will be assessed by making repeated measurements in the same subjects on different occasions. Sensitivity to change will be assessed by comparing values before and after changing smoking habit. Finally, the validity of the biomarkers will be assessed by comparing them to previous measures of smoke exposure (CO, NNAL and NNAL-glc) and to clinically defined endpoints: symptoms, the St. George's Respiratory Questionnaire and post bronchodilator lung function. With regard to the latter measures, preliminary data indicate that symptoms can be detected in "asymptomatic" smokers and that these can change with a harm reduction strategy.
NCT00468234 ↗ Validation of Biomarkers of Exposure and Host Response Completed University of Nebraska N/A 2005-12-01 The proposed study will evaluate biomarkers measured in exhaled breath condensate (EBC) for the purpose of assessing clinical strategies of harm reduction. It will take advantage of a recently developed device that permits collection of exhaled breath condensate reproducibly, with minimal subject effort and with no oral contamination. The major goal of the trial is to provide evidence to validate biomarkers in EBC. This will be accomplished by collecting samples from asymptomatic smokers before and after inducing a change in their smoking habit (cessation or reduction) with the aid of partial nicotine replacement. Measures to be made in EBC include H2O2, the most widely explored biomarker in this "body" fluid. Methods that reliably can quantify levels in normal non-smokers and in asymptomatic smokers will be used. Two fold increases in smokers have been reported by in several reports and confirmed in preliminary data by the investigators. In addition, other biomarkers of oxidant stress: TBARs, 8-isoprostane and nitrotyrosine will be quantified using standard methods. Biomarkers quantified in EBC will be assessed for reliability (i.e. reproducibility and for sensitivity) to change and for validity (by comparison to clinically defined endpoints and previously validated measures of exposure). Reproducibility will be assessed by making repeated measurements in the same subjects on different occasions. Sensitivity to change will be assessed by comparing values before and after changing smoking habit. Finally, the validity of the biomarkers will be assessed by comparing them to previous measures of smoke exposure (CO, NNAL and NNAL-glc) and to clinically defined endpoints: symptoms, the St. George's Respiratory Questionnaire and post bronchodilator lung function. With regard to the latter measures, preliminary data indicate that symptoms can be detected in "asymptomatic" smokers and that these can change with a harm reduction strategy.
NCT00482690 ↗ Analysis of Aldehyde Biomarkers of Exposure and Host Response Unknown status R.J. Reynolds Tobacco Company N/A 2006-03-01 Analysis of aldeyde biomarkers of exposure and host response The purpose of this prospective, open-label, clinical trial is to establish the feasibility and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies of smoking. This will be accomplished by measuring selected markers in EBC believed related to the pathogenesis of lung disease before and after a smoking cessation intervention.
NCT00482690 ↗ Analysis of Aldehyde Biomarkers of Exposure and Host Response Unknown status University of Nebraska N/A 2006-03-01 Analysis of aldeyde biomarkers of exposure and host response The purpose of this prospective, open-label, clinical trial is to establish the feasibility and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies of smoking. This will be accomplished by measuring selected markers in EBC believed related to the pathogenesis of lung disease before and after a smoking cessation intervention.
NCT01087905 ↗ Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines Completed Alere Wellbeing Phase 4 2010-04-01 Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.
NCT01087905 ↗ Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines Completed Consumer Wellness Solutions Phase 4 2010-04-01 Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nicotine Polacrilex

Condition Name

Condition Name for Nicotine Polacrilex
Intervention Trials
Smoking 4
Tobacco Use Disorder 3
Smoking Cessation 3
Tobacco Use 2
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Condition MeSH

Condition MeSH for Nicotine Polacrilex
Intervention Trials
Tobacco Use Disorder 6
Depressive Disorder 1
Depression 1
Behavior, Addictive 1
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Clinical Trial Locations for Nicotine Polacrilex

Trials by Country

Trials by Country for Nicotine Polacrilex
Location Trials
United States 21
Canada 1
Sweden 1
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Trials by US State

Trials by US State for Nicotine Polacrilex
Location Trials
North Carolina 4
Nebraska 4
Kansas 2
Oklahoma 2
New Jersey 1
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Clinical Trial Progress for Nicotine Polacrilex

Clinical Trial Phase

Clinical Trial Phase for Nicotine Polacrilex
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Nicotine Polacrilex
Clinical Trial Phase Trials
Completed 17
Terminated 2
Active, not recruiting 1
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Clinical Trial Sponsors for Nicotine Polacrilex

Sponsor Name

Sponsor Name for Nicotine Polacrilex
Sponsor Trials
Duke University 4
National Cancer Institute (NCI) 3
University of Oklahoma 2
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Sponsor Type

Sponsor Type for Nicotine Polacrilex
Sponsor Trials
Other 22
Industry 13
NIH 4
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