Extended Varenicline Treatment for Smoking Among Cancer Patients
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.
Behavioral: Smoking Cessation Counseling
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial|
- Point prevalence tobacco abstinence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]7-day CO-verified tobacco abstinence.
- Point prevalence tobacco abstinence [ Time Frame: Week 52 ] [ Designated as safety issue: No ]7-day CO-verified tobacco abstinence.
- Quality of Life [ Time Frame: Weeks 24 & 52 ] [ Designated as safety issue: Yes ]The Short-Form Health Survey (SF-12) will assess Quality of Life (QOL). This scale yields physical and mental subscales, has been used to assess cancer patient QOL, has demonstrated validity and reliability, and has been used in smoking cessation trials with cancer patients. In addition, the investigators will compare treatment arms in terms of the frequency of severe side effects (individual and total).
- Point prevalence tobacco abstinence [ Time Frame: Weeks 12 and 26 ] [ Designated as safety issue: No ]7-day CO-verified tobacco abstinence.
- Smoking Rate [ Time Frame: Week 52 ] [ Designated as safety issue: No ]Monitor changes in smoking rates (i.e., # cigarettes/day).
- Prolonged Abstinence [ Time Frame: Weeks 12, 24, 26, and 52 ] [ Designated as safety issue: No ]Relapse defined as 7 consecutive days of self-reported smoking, after a 2-week grace period.
- Continuous Abstinence [ Time Frame: Week 12, 24, 26, and 52 ] [ Designated as safety issue: No ]No smoking between the quit day and the follow-up measure.
- Time to 7-day relapse [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Lapse & Recovery events [ Time Frame: Week 52 ] [ Designated as safety issue: No ]Timing and rates of lapses (smoking episodes not lasting 7 days) and recovery events (return to 24-hour abstinence).
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Standard Varenicline Treatment
12 weeks of active varenicline + 12 weeks of placebo + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
Days 85-168: Placebo - 1.0mg twice daily orally
Other Name: ChantixDrug: Placebo Behavioral: Smoking Cessation Counseling
Experimental: Extended Varenicline Treatment
24 weeks of active varenicline + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-168: 1.0mg twice daily orally
Other Name: ChantixBehavioral: Smoking Cessation Counseling
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756885
|Contact: Amanda M Kaufmannfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Anna Veluz-Wilkins, MA 312-503-3098 email@example.com|
|Principal Investigator: Brian Hitsman, PhD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Amanda M Kaufmann 215-746-8434 firstname.lastname@example.org|
|Principal Investigator: Robert A Schnoll, PhD|
|Principal Investigator:||Robert A Schnoll, PhD||University of Pennsylvania|