Tobacco Dependence

Interested smokers phoned a central research office, where they completed a telephone screen to determine eligibility. Participants who passed the telephone screen were invited to an informational session where they provided written informed consent. Next, participants completed three in-person baseline sessions. During the first baseline session, participants underwent further screening including collection of relevant medical history information, vital signs measurements, and a carbon monoxide (CO) breath test. Additionally, at this visit, participants completed several demographic, smoking history, and tobacco dependence questionnaires.
After additional medical assessments at two more baseline sessions (e.g., brachial artery reactivity, carotid intima media thickness, and small particle lipoprotein testing), participants were randomized to one of six treatment conditions: 1) Bupropion SR (150 mg, bid for 9 weeks total: 1week pre-quit and 8 weeks post-quit); 2) Nicotine Lozenge (2 or 4 mg, based on appropriate dose for dependence level per package instructions, for 12 weeks post-quit); 3) Nicotine Patch (24-hour patch; 21, 14, and 7mg; titrated down over 8 weeks post-quit); 4) Nicotine Patch (24-hour patch; 21, 14, and 7mg; titrated down over 8 weeks post-quit) + Nicotine Lozenge (2 or 4 mg, based on appropriate dose for dependence level per package instructions, for 12 weeks post-quit) combination therapy; 5) Bupropion SR (150 mg, bid for 9 weeks total: 1week pre-quit and 8 weeks post-quit) + Nicotine Lozenge (2 or 4 mg, based on appropriate dose for dependence level per package instructions, for 12 weeks post-quit) combination therapy; or 6) Placebo. It should be noted that “pre-quit” and “post-quit” in this manuscript refer, respectively, to the periods of time prior to and following a patient’s targeted quit date. There were five distinct placebo conditions, matched to each of the active treatment conditions (i.e., placebo bupropion, placebo lozenge, placebo patch, placebo patch + lozenge and placebo bupropion + lozenge; see Figure 2). Participants received study medication at each study visit and returned any unused medication at the following visit. Randomization was double-blind and used a blocked randomization scheme with gender and self-reported race (white/non-white) as the blocking variables. Staff did not know to which type(s) of medication (i.e., patch, pill, and/or lozenge) a participant would be assigned until the moment of randomization, and study staff were blinded to whether the medication was active or placebo. In addition to pharmacotherapy, all participants received six one-on-one counseling sessions based upon the PHS Guideline.1 Study staff who provided counseling and conducted study sessions were bachelor-level trained case managers, supervised by a licensed clinical psychologist. Sessions lasted 10–20 minutes and occurred over 7 weeks with the first two counseling sessions occurring prior to quitting and the subsequent five occurring on the quit date or thereafter (see Figure 1). The last baseline visit, where randomization occurred and medication was dispensed, took place between 8 and 15 days pre-quit to ensure the bupropion up-titration schedule could be completed. Participants were instructed to start medications on the designated quit date, except for bupropion SR, which they were instructed to initiate 1 week prior to the quit date as per the package insert instructions. Participants had study visits on their quit day, and at 1-, 2-, 4- and 8-weeks post-quit. At study visits, vital signs, adverse events and smoking status were all recorded.