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

NCT00781599 | Completed Results

• 1 other identifier: 11500
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Smokers

Keywords

African american; smokers; smoking cessation; African American smokers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cotinine Verified 7 Day Point Prevalence Smoking Abstinence

  Month 3

• Carbon Monoxide-verified Abstinence

  Month 1

• Carbon Monoxide-verified Abstinence

  Month 2

Study Arms (2)

1

ACTIVE COMPARATOR

Chantix for 3 months and Standard Counseling

Drug: Chantix; Behavioral: Standard Counseling

2

EXPERIMENTAL

Chantix for 3 months and Adherence Counseling

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

Interventions

Chantix DRUG

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

Also known as: varenicline

1; 2

Adherence Counseling BEHAVIORAL

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.

2

Standard Counseling BEHAVIORAL

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nikki Nollen, PhD, MA: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Nikki Nollen
• Organization: University of Kansas Medical Center

NNOLLEN@kumc.edu

(913) 588-3784

Study Officials

• Nicole Nollen, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 11, 2012
• Results First Posted: June 27, 2012

Record last verified: 2012-06

Locations

US (1)