George R Krautter1, Michael F Borgerding2. 1. Department of Research and Development, R. J. Reynolds Tobacco Company, Winston-Salem, NC krauttg@rjrt.com. 2. Department of Research and Development, R. J. Reynolds Tobacco Company, Winston-Salem, NC.
Abstract
INTRODUCTION: The objectives of this trial were to investigate short-term changes in product usage, tobacco-related biomarkers of exposure, and subjective effects in smokers who switched to dissolvable tobacco (Camel Orbs) use. METHODS: Participants were randomized into 1 of 4 groups (continued smoking, switched to consuming Orbs, switched to dual use of cigarettes and Orbs, and tobacco abstinent) and confined for 6 days with dietary restrictions. Most measurements were at baseline and days 1, 3, and 5 of intervention. Mouth-level tar and nicotine exposures were estimated by filter tip analysis. Twenty biomarkers were quantified in 24-hr urine; 4 were quantified in blood/plasma (carboxyhemoglobin, nicotine, cotinine, and thiocyanate). Ratings for nicotine dependence and withdrawal symptoms were scored. RESULTS: After 5 days, substantial and statistically significant reductions (~30%-90%) in all biomarkers were observed in the Orbs and abstinent groups compared to baseline. Numerous smaller reductions (~7%-30%) were also noted in the continued smoking and dual-use groups (generally similar in magnitude for both groups). Subjective questionnaire findings indicated greater withdrawal discomfort levels throughout the intervention period for the nonsmoking groups. For subjects that continued smoking, clinical confinement conditions did not significantly alter product use behavior and toxicant exposure profile compared to baseline. CONCLUSIONS: Substantial reductions in toxicant exposure occurred for participants that did not smoke. Cigarette smokers that switched to Orbs use showed reductions in all biomarkers, similar to abstinent group. Changes in toxicant exposure for the dual-use group were similar to the continued-smoking group, consistent with minimal changes observed in that group's product use behavior (small reduction in cigarettes per day and small increase in Orbs use).
RCT Entities:
INTRODUCTION: The objectives of this trial were to investigate short-term changes in product usage, tobacco-related biomarkers of exposure, and subjective effects in smokers who switched to dissolvable tobacco (Camel Orbs) use. METHODS:Participants were randomized into 1 of 4 groups (continued smoking, switched to consuming Orbs, switched to dual use of cigarettes and Orbs, and tobacco abstinent) and confined for 6 days with dietary restrictions. Most measurements were at baseline and days 1, 3, and 5 of intervention. Mouth-level tar and nicotine exposures were estimated by filter tip analysis. Twenty biomarkers were quantified in 24-hr urine; 4 were quantified in blood/plasma (carboxyhemoglobin, nicotine, cotinine, and thiocyanate). Ratings for nicotine dependence and withdrawal symptoms were scored. RESULTS: After 5 days, substantial and statistically significant reductions (~30%-90%) in all biomarkers were observed in the Orbs and abstinent groups compared to baseline. Numerous smaller reductions (~7%-30%) were also noted in the continued smoking and dual-use groups (generally similar in magnitude for both groups). Subjective questionnaire findings indicated greater withdrawal discomfort levels throughout the intervention period for the nonsmoking groups. For subjects that continued smoking, clinical confinement conditions did not significantly alter product use behavior and toxicant exposure profile compared to baseline. CONCLUSIONS: Substantial reductions in toxicant exposure occurred for participants that did not smoke. Cigarette smokers that switched to Orbs use showed reductions in all biomarkers, similar to abstinent group. Changes in toxicant exposure for the dual-use group were similar to the continued-smoking group, consistent with minimal changes observed in that group's product use behavior (small reduction in cigarettes per day and small increase in Orbs use).
Authors: Dina M Jones; Ban A Majeed; Scott R Weaver; Kymberle Sterling; Terry F Pechacek; Michael P Eriksen Journal: Am J Health Behav Date: 2017-09-01
Authors: Pavel N Lizhnyak; Brendan Noggle; Lai Wei; Jeffery Edmiston; Elizabeth Becker; Ryan A Black; Mohamadi Sarkar Journal: Harm Reduct J Date: 2022-08-17