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Chunk #13 — Methods — Procedures

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A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies.
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(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