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Clinical Trial
. 2015 Sep-Oct;47(4):331-5.
doi: 10.1080/02791072.2015.1073412. Epub 2015 Aug 28.

Biochemical Validation of Self-Reported Smokeless Tobacco Abstinence among Smokeless Tobacco Users: Results from a Clinical Trial of Varenicline in India

Raka Jain  1 , Sonali Jhanjee  1 , Veena Jain  2 , Tina Gupta  1 , Swati Mittal  2 , Prashant Chauhan  1 , Rahul Raghav  1 , Patricia Goelz  3 , Robert A Schnoll  3
Affiliations
Clinical Trial

Biochemical Validation of Self-Reported Smokeless Tobacco Abstinence among Smokeless Tobacco Users: Results from a Clinical Trial of Varenicline in India

Raka Jain et al. J Psychoactive Drugs. 2015 Sep-Oct.

Abstract

The validity of self-reported tobacco use is often questioned given the potential for underestimation of use. This study used data from a double-blind, placebo-controlled clinical trial of varenicline for smokeless tobacco dependence in India to evaluate the accuracy of self-reported smokeless tobacco cessation using biochemical validation procedures and to evaluate correlates of reporting inaccuracy. Smokeless tobacco users attending a dental clinic at AIIMS were randomized to placebo or varenicline; all participants received counseling. Detailed smokeless tobacco use was recorded and abstinence was defined as cotinine-verified 7-day point prevalence cessation (cotinine < 50 ng/ml) and breath CO > 10 ppm at the end of 12 weeks of treatment. One-half of study completers (82/165) self-reported abstinence. Biochemical verification confirmed that (65.9%) subjects provided accurate self-reports while (34.1%) participants underreported tobacco use. These data indicate poor agreement between self-reported and biochemically confirmed abstinence (κ = -0.191). Underreporters of tobacco use had significantly higher baseline cotinine (p < 0.05), total craving (p < 0.012), and negative reinforcement craving (p < 0.001) vs. those whose self-reports were correctly verified. These findings provide evidence to support the need for biochemical validation of self-reported abstinence outcomes among smokeless tobacco users in cessation programs in India and identify high levels of pretreatment cotinine and craving levels as potential correlates of false reporting.

Keywords: biochemical validation; self-report; smokeless tobacco users; urine; varenicline.

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Conflict of interest statement

Statement of Interest

Dr. Schnoll has served as a consultant to GlaxoSmithKline and Pfizer, and Pfizer provided the study medication and placebo for this study free of charge.

References

    1. Baker TB, Piper ME, McCarthy DE, Bolt DM, Smith SS, Kim S, Toll BA. Time to first cigarette in the morning as an index of ability to quit smoking: implications for nicotine dependence. Nicotine and Tobacco Research. 2007;9(Suppl4):S555–570. doi: 10.1080/14622200701673480. - DOI - PMC - PubMed
    1. Benowitz NL, Jacob P, Ahijevych K, Jarvis MJ, Hall S, LeHouezec J, Velicer W. Biochemical verification of tobacco use and cessation. Nicotine and Tobacco Research. 2002;4(2):149–159. - PubMed
    1. Boyd NR, Windsor RA, Perkins LL, Lowe JB. Quality of measurement of smoking status by self-report and saliva cotinine among pregnant women. Maternal Child Health Journal. 1998;2(2):77–83. Retrieved from link.springer.com/article/10.1023%2FA%3A1022936705438. - PubMed
    1. Dhavan P, Bassi S, Stigler MH, Arora M, Gupta VK, Perry CL, Reddy KS. Using Salivary Cotinine to Validate Self-Reports of Tobacco Use by Indian Youth Living in Low-Income Neighborhoods. Asian Pacific Journal of Cancer Prevention. 2011;12(10):2551–2554. Retrieved from europepmc.org/abstract/MED/22320954. - PMC - PubMed
    1. Dolcini MM, Adler NE, Ginsberg D. Factors influencing agreement between self-reports and biological measures of smoking among adolescents. Journal of Research on Adolescence. 1996;6(4):515–542. Retrieved from psycnet.apa.org/psycinfo/1997-02897-006.

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