title: Biochemical Validation of Self-Reported Smokeless Tobacco Abstinence among Smokeless Tobacco Users: Results from a Clinical Trial of Varenicline in India.
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.
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Raka
authors: R
authors: Jain
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Sonali
authors: S
authors: Jhanjee
authors: b Centre for Dental Education and Research , All India Institute of Medical Sciences , New Delhi , India.
authors: Veena
authors: V
authors: Jain
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Tina
authors: T
authors: Gupta
authors: b Centre for Dental Education and Research , All India Institute of Medical Sciences , New Delhi , India.
authors: Swati
authors: S
authors: Mittal
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Prashant
authors: P
authors: Chauhan
authors: a National Drug Dependence Treatment Centre , All India Institute of Medical Sciences , New Delhi , India.
authors: Rahul
authors: R
authors: Raghav
authors: c Department of Psychiatry and Abramson Cancer Center , University of Pennsylvania , Philadelphia , PA.
authors: Patricia
authors: P
authors: Goelz
authors: c Department of Psychiatry and Abramson Cancer Center , University of Pennsylvania , Philadelphia , PA.
authors: Robert A
authors: RA
authors: Schnoll
mesh_terms: D000328:Adult; D001944:Breath Tests; D002248:Carbon Monoxide / Q000032:analysis; D003367:Cotinine / Q000652:urine*; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D018722:Nicotinic Agonists / Q000627:therapeutic use*; D057566:Self Report; D020340:Tobacco Use Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000188:drug therapy; D000068580:Varenicline / Q000627:therapeutic use*
chemical_list: D018722:Nicotinic Agonists; D002248:Carbon Monoxide; D003367:Cotinine; D000068580:Varenicline
keywords: biochemical validation; self-report; smokeless tobacco users; urine; varenicline