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

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

Study Overview

• Status: Completed
• Conditions: Smokers
• Intervention / Treatment: Drug: Chantix; Behavioral: Standard Counseling; Behavioral: Adherence Counseling

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Chantix for 3 months and Standard Counseling	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; Other Names: varenicline; Behavioral: 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.
Experimental: 2; Chantix for 3 months and Adherence Counseling	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; Other Names: varenicline; Behavioral: 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.; Behavioral: 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.

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

Collaborators and Investigators

• Sponsor: Nikki Nollen, PhD, MA
• Investigators: Principal Investigator: Nicole Nollen, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: October 27, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 29, 2008

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: smoking cessation; smokers; African american; African American smokers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 11500