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

Nikki Nollen, PhD, MA

Status: Completed

Conditions: Smokers

Treatments: Behavioral: Adherence Counseling; Behavioral: Standard Counseling; Drug: Chantix

Study type: Interventional

Funder types: Other

Identifiers

NCT00781599

11500

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

1

Active Comparator group

Description:

Chantix for 3 months and Standard Counseling

Treatment:

Drug: Chantix

Behavioral: Standard Counseling

2

Experimental group

Description:

Chantix for 3 months and Adherence Counseling

Treatment:

Behavioral: Adherence Counseling

Drug: Chantix

Behavioral: Standard Counseling