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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikki Nollen, PhD, MA, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00781599
First received: October 27, 2008
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Smokers
Drug: Chantix
Behavioral: Adherence Counseling
Behavioral: Standard Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Percent Compliance With Chantix [ Time Frame: Months 1, 2, 3 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Cotinine Verified 7 Day Point Prevalence Smoking Abstinence [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.

  • Carbon Monoxide-verified Abstinence [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.

  • Carbon Monoxide-verified Abstinence [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.


Enrollment: 72
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Chantix for 3 months and Standard Counseling
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
Other Name: varenicline
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.
Experimental: 2
Chantix for 3 months and Adherence Counseling
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
Other Name: varenicline
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781599

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Nikki Nollen, PhD, MA
Investigators
Principal Investigator: Nicole Nollen, PhD University of Kansas
  More Information

No publications provided

Responsible Party: Nikki Nollen, PhD, MA, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00781599     History of Changes
Other Study ID Numbers: 11500
Study First Received: October 27, 2008
Results First Received: April 19, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
African american
smokers
smoking cessation
African American smokers

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014