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Completed

NCT Number: NCT00781599

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: varenicline

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.

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.

Primary outcomes

  1. Percent Compliance With Chantix

    Time frame: Months 1, 2, 3

    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.

Secondary outcomes

  1. Cotinine Verified 7 Day Point Prevalence Smoking Abstinence

    Time frame: Month 3

    Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.

  2. Carbon Monoxide-verified Abstinence

    Time frame: Month 1

    Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.

  3. Carbon Monoxide-verified Abstinence

    Time frame: Month 2

    Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.

Sponsors and collaborators

Lead sponsor

Nikki Nollen, PhD, MA

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2008
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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