Extended Varenicline Treatment for Smoking Among Cancer Patients
Status:
Completed
Trial end date:
2018-05-31
Target enrollment:
Participant gender:
Summary
Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke
following diagnosis and treatment. With medical advances in cancer care yielding a growing
constituency of cancer survivors, addressing nicotine dependence in this population is a
priority. While PHS guidelines recommend acute treatment durations with approved medications
for tobacco use, extending the duration of treatment beyond the standard treatment duration
significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to
abstinence following a lapse. Varenicline may be particularly effective for cancer patients
given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer
patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks
placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize
that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed
abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in
the extended therapy group versus the standard therapy group, and there will be no
significant differences between groups in terms of severe side effects, and 3) Improved
affect and reduced cognitive impairment will mediate the effect of extended therapy on quit
rates.