N/A
N=72
Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
Smokers
Bottom Line
View on ClinicalTrials.gov: NCT00781599 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Percent Compliance With Chantix — 90.7; 85.8; 87.1; 91.7 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chantix (Drug); Adherence Counseling (Behavioral); Standard Counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nikki Nollen, PhD, MA
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Compliance With Chantix |
90.7; 85.8; 87.1; 91.7; 89.2; 82.1 | — |
| SECONDARY Cotinine Verified 7 Day Point Prevalence Smoking Abstinence |
9; 8 | — |
| SECONDARY Carbon Monoxide-verified Abstinence |
6; 5 | — |
| SECONDARY Carbon Monoxide-verified Abstinence |
6; 5 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00781599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.