Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
NCT ID: NCT00781599
Last Updated: 2012-07-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2008-10-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Chantix for 3 months and Standard Counseling
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
Standard Counseling
Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving.
2
Chantix for 3 months and Adherence Counseling
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
Adherence Counseling
Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of adherence behavioral change.
Standard Counseling
Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving.
Interventions
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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
Adherence Counseling
Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of adherence behavioral change.
Standard Counseling
Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-75 years of age
* Smoke more than 10 cigarettes per day
* Have a functioning telephone number
* Be interested in quitting smoking
* Be willing to take 3 months of Chantix
* Be willing to complete all study visits
Exclusion Criteria
* Evidence or history of clinically significant allergic reactions to Chantix
* Cardiovascular event in the past month
* History of alcohol or drug abuse/dependency in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder
* Psychosis, bipolar or eating disorder
* Use of antidepressants, antipsychotics, mood stabilizers/anticonvulsants or naltrexone
* Use of tobacco products other than cigarettes
* Use of nicotine replacement therapy, bupropion, clonidine or nortriptyline in the month prior to enrollment
* Prior use of Chantix
* Women who are pregnant, contemplating getting pregnant or breastfeeding
* Plans to move from Kansas City during the 3 month treatment phase
* Another household member enrolled in the study
18 Years
75 Years
ALL
No
Sponsors
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Nikki Nollen, PhD, MA
OTHER
Responsible Party
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Nikki Nollen, PhD, MA
Assistant Professor
Principal Investigators
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Nicole Nollen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Other Identifiers
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11500
Identifier Type: -
Identifier Source: org_study_id