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

NCT00781599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2012-07-11

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Nikki Nollen, PhD, MA

    lead OTHER

Principal Investigators

  • Nicole Nollen, PhD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781599 on ClinicalTrials.gov