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Applied Longitudinal Data Analysis Modeling Change And Event Occurrence

Human behavioral pharmacology.

The FDA has considered reducing the maximum allowable nicotine content in cigarettes to facilitate quitting in dependent smokers. To potentially inform clinical research on nicotine reduction, this laboratory-based study used a within-subjects forced-choice paradigm to assess dose-related declines in relative nicotine reinforcement in dependent adult smokers (N=37). The aim was to establish the clinically predictive validity of this paradigm by relating findings to results from the Donny et al. (2015) clinical trial on smoking reduction with reduced nicotine cigarettes. In five sessions following overnight abstinence, SPECTRUM research cigarettes varying in nicotine contents (17.4, 11.2, 5.5, 2.3, and 1.3 mg/g; one “NIC” dose per session), were compared to a very low nicotine content cigarette (“VLNC”; 0.4 mg/g). Each session began with four 4-puff exposure trials (2 each NIC or VLNC, identified by letter codes). Assessment of pleasurable sensory perceptions of smoking occurred immediately following each exposure trial. Next were four choice trials in which NIC and VLNC cigarettes were presented concurrently; participants were instructed to take four puffs from any combination of the cigarettes they wanted, totaling 16 choices. Overall, the number of NIC choices and the magnitude of difference in pleasurable sensory perceptions (NIC – VLNC) increased significantly as the nicotine content condition increased. Sensory responses were found to mediate the relationship between nicotine content condition and choice. Differences in choice and sensory responses due to menthol preference and/or ethnicity were also found. However, the pattern NIC choices across nicotine content conditions were not consistent with the pattern of results observed by Donny et al. (2015), failing to establish clinically predictive validity of the forced choice procedure. Although this within-subjects acute choice procedure did not closely relate to the between-subjects ad lib smoking behavior across weeks in Donny et al., this procedure may combine with other data to suggest a nicotine reduction to ≤2.3 mg/g may attenuate reinforcement.

Validating a Procedure to Assess Declines in Acute Cigarette Self-Administration due to Reductions in Nicotine Content

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Validating a Procedure to Assess Declines in Acute Cigarette Self-Administration due to Reductions in Nicotine Content