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Sponsored by: |
University of Kansas |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00781599 |
Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3
Condition | Intervention |
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Smokers |
Drug: Chantix Other: Chantix and Induction Support Counseling |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers |
Estimated Enrollment: | 72 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Chantix for 3 months
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Drug: Chantix
Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3
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2: Experimental
Chantix for 3 months and Induction Support Counseling
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Other: Chantix and Induction Support Counseling
Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3, Induction Support counseling on days 8, 12, 20 and months 1 and 2
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nicole Nollen, PhD | 913-588-3784 | nnollen@kumc.edu |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Nicole Nollen, PhD 913-588-3784 nnollen@kumc.edu |
Principal Investigator: | Nicole Nollen, PhD | University of Kansas |
Responsible Party: | University of Kansas Medical Center ( Nicole Nollen PhD ) |
Study ID Numbers: | 11500 |
Study First Received: | October 27, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00781599 History of Changes |
Health Authority: | United States: Institutional Review Board |
African american smokers smoking cessation African American smokers |
Smoking Varenicline |