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

Smokers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781599
• Other study ID #: 11500
• Status: Completed
• Phase: N/A
• First received: October 27, 2008
• Last updated: June 27, 2012
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smokers

Intervention

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

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Nikki Nollen, PhD, MA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No