Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers

Not Applicable

Completed

• Conditions: Smokers
• Interventions: Drug: Chantix; Behavioral: Standard Counseling; Behavioral: Adherence Counseling

• Registration Number: NCT00781599
• Lead Sponsor: Nikki Nollen, PhD, MA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2012-04-19
• Results First Submitted QC: 2012-05-24
• Status Verified: 2012-06
• Results First Posted: 2012-06-27
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• African American
• 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

• Renal impairment
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chantix	Chantix for 3 months and Standard Counseling
1	Standard Counseling	Chantix for 3 months and Standard Counseling
2	Adherence Counseling	Chantix for 3 months and Adherence Counseling
2	Standard Counseling	Chantix for 3 months and Adherence Counseling
2	Chantix	Chantix for 3 months and Adherence Counseling

Primary Outcome Measures

Name	Time	Method
Percent Compliance With Chantix	Months 1, 2, 3	Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.

Secondary Outcome Measures

Name	Time	Method
Cotinine Verified 7 Day Point Prevalence Smoking Abstinence	Month 3	Smoking cessation verified by salivary cotinine (COT). A COT of \<20 ng/ml indicated smoking abstinence.
Carbon Monoxide-verified Abstinence	Month 2	Carbon monoxide-verified abstinence determined as a measure of \<10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States