UW-CTRI Triple Medication Smoking Cessation Study

Recent research suggests that a new combination therapy may be especially effective in
increasing long-term abstinence from smoking. A key purpose of the proposed study is to
examine what types of tolerability concerns, if any, emerge from the simultaneous use of
three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge)
and the timing of those events, in order to better assess how the use of this combination of
tobacco cessation medicines can be most effectively and safely delivered and monitored. Study
participants will take the three medications for 12 weeks in a manner consistent with
labeling. Adverse events will be assessed at all study visits.

Inclusion Criteria:

- Age >17 years;

- >=5 cigarettes/day for the previous 6 months;

- alveolar CO >= 6 ppm; able to read, write and speak English;

- planning to remain in the intervention catchment area for at least 4 months; not
currently taking bupropion or varenicline;

- if the participant is currently using NRT, s/he agrees to use only study medication
for the duration of the study;

- free of medical contraindications to NRT and varenicline; and,

- if participant is a woman of childbearing potential, using an approved method of birth
control during treatment.

Exclusion Criteria:

- Current diagnosis of/treatment for psychosis or bipolar disorder;

- suicidal ideation within the past 12 months; any history of suicide attempts; *
significant hepatic or renal impairment; history of significant allergic reactions to
varenicline or any type of NRT in the past;

- use of any investigational drugs in the previous 30 days. -