Participant recruitment and randomization
Recruitment occurred from May 2009 to August 2010 at
a total of eight homeless shelters in Minneapolis/St Paul,
Minnesota. Recruitment was conducted at health fairs
and via staff informational sessions and posted flyers at
the study sites. Study eligibility criteria included being
currently homeless and having lived in the Twin Cities for
6 months, having smoked at least one cigarette per day
in the past 7 days and at least 100 cigarettes in their
life-time, aged 18 years, and willing to use nicotine
patches for 8 weeks and participate in counseling ses-sions. Participants were classified as homeless based upon
the Stewart B. McKinney Act passed by the US congress
in 1987, in which homelessness was defined as anyone
lacking ‘a fixed, regular and adequate nighttime resi-dence’ or anyone staying at ‘a supervised publicly or pri-vately operated shelter designed to provide temporary
living accommodations, transitional housing, or other
supportive housing program or a public or private place
not meant for human habitation’ [12]. Smoking status
was confirmed with an exhaled carbon monoxide (CO)
monitor using a cut-off of 5 parts per million (p.p.m.).
Exclusion criteria included: pregnancy, use of another
tobacco cessation aid in the previous 30 days, severe cog-nitive impairment, suicidal ideation in the last 14 days,
a major medical condition within the prior month or
scoring>5 on items assessing psychotic symptoms from
the nine-item Mini International Neuropsychiatric Inter-view (MINI) [13].
At the baseline visit, pre-assigned randomization
numbers prepared by the study statistician determined
into which study arm the participant would be enrolled.
The assignment to MI versus standard care was not
blinded to participants. Sequential enrollment continued
until a total of 430 participants were randomized into the
study.