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

Study Overview
=================
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

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

Conditions
-----------------
Smokers

Intervention / Treatment
-----------------
* Drug: Chantix
* Behavioral: Adherence Counseling
* Behavioral: Standard Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Chantix for 3 months and Standard Counseling | Drug: Chantix<br>* 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<br>* Other names: varenicline;Behavioral: Standard Counseling<br>* 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.<br>|
| Experimental: 2<br>Chantix for 3 months and Adherence Counseling | Drug: Chantix<br>* 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<br>* Other names: varenicline;Behavioral: Adherence Counseling<br>* 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.<br>Behavioral: Standard Counseling<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Compliance With Chantix | 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. | Months 1, 2, 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cotinine Verified 7 Day Point Prevalence Smoking Abstinence | Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence. | Month 3 | 
| Carbon Monoxide-verified Abstinence | Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. | Month 1 | 
| Carbon Monoxide-verified Abstinence | Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers. | Month 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
African american, smokers, smoking cessation, African American smokers