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Original Research

Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

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Pages 475-482 | Published online: 28 Sep 2011
 

Abstract

Background

Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials.

Objectives

To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy.

Research design

Secondary data analysis of a randomized pilot study.

Participants

46 moderate-to-heavy (>10 cigarettes per day) African-American smokers.

Main measures

Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY) in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded.

Results

Participants were a mean age of 48 years (SD = 13), predominately female (59%), low income (60% < $1800 monthly family income), and smoked an average of 17 (SD = 7) cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001). Participants with discordant counts (n = 7) had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005), but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004) than participants with matching phone and in-person counts (n = 39).

Conclusion

Unannounced telephone pill counts appear to be a reliable and practical method for measuring adherence to smoking cessation pharmacotherapy.

Acknowledgments

Contributors: None to report.

Funder: This study was supported by a grant from the (University of Kansas Cancer Center, Kansas City, KS) and a contract from (Pfizer Global Pharmaceuticals, New York, NY) (GA3051YA). Pfizer provided study medication, but played no role in the study design, conduct of the study, or interpretation and analysis of the data.

Prior presentations: This paper was presented as a poster at the 2011 (February) Annual Meeting of the Society of Research on Nicotine and Tobacco, Toronto, ON.

Disclosure

Nia Thompson: No conflicts of interest.

Nicole L Nollen: This study was supported by a contract from Pfizer Global Pharmaceuticals to Dr Nollen (GA3051YA).

Pfizer provided study medication, but played no role in the study design, conduct of the study, or interpretation and analysis of the data.

Niaman Nazir: No conflicts of interest.

Lisa Sanderson Cox: No conflicts of interest.

Babalola Faseru: No conflicts of interest.

Kathy Goggin: No conflicts of interest.

Jasjit S Ahluwalia: Dr Ahluwalia serves as a paid consultant to Pfizer Inc, which markets varenicline.