A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol

Table 2 Nicotine content dosing schedule for study

Phase	Baseline I	Baseline II	Randomized Double-Blind Phase					Treatment Choice Phase
Week(s)	1	2	3	3	3	3	6	12
Cigarette type	Own Brand	Usual Nicotine Research Cigarettes	Reduced Nicotine Step 1	Reduced Nicotine Step 2	Reduced Nicotine Step 3	Reduced Nicotine Step 4	Reduced Nicotine Step 5	Variable
Spectrum Code: regular		600	500	400	300	200	102
Spectrum Code: menthol		601	501	401	301	201	103
Approximate nicotine content in mgs per cigarette (mg/gram)^a
RNC	Around 13 mg^b	11.6	7.4	3.3	1.4	0.7	0.2	Variable
RNC	(19)	16.5	(10.6)	(4.7)	(1.9)	(0.9)	(0.3)	Variable
UNC	Around 13 mg^b	11.6	11.6	11.6	11.6	11.6	11.6	Variable
UNC	(19)	(16.5)	(16.5)	(16.5)	(16.5)	(16.5)	(16.5)	Variable

^aThese are averages of menthol/non-menthol cigarettes at each level based on estimated 0.7 g tobacco content per cigarette and nicotine concentrations based on Richter et al. [27]
^bEstimated mean nicotine content and concentration based on Connolly et al. [66]

ISSN: 1471-2458