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Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial
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.
Details
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 207 |
| Start date | 2013-01 |
| Completion | 2018-05-31 |
Conditions
- Nicotine Dependence
Interventions
- Varenicline
- Placebo
- Smoking Cessation Counseling
Primary outcomes
- 7-day CO-verified Tobacco Abstinence — Weeks 24 & 52
Number of Participants with Verified 7 Day Tobacco Abstinence.
Countries
United States