Extended Varenicline Treatment for Smoking Among Cancer Patients
|ClinicalTrials.gov Identifier: NCT01756885|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2012
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: Varenicline Drug: Placebo Behavioral: Smoking Cessation Counseling||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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
- Point prevalence tobacco abstinence [ Time Frame: Week 24 ]7-day CO-verified tobacco abstinence.
- Point prevalence tobacco abstinence [ Time Frame: Week 52 ]7-day CO-verified tobacco abstinence.
- Quality of Life [ Time Frame: Weeks 24 & 52 ]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 ]7-day CO-verified tobacco abstinence.
- Smoking Rate [ Time Frame: Week 52 ]Monitor changes in smoking rates (i.e., # cigarettes/day).
- Prolonged Abstinence [ Time Frame: Weeks 12, 24, 26, and 52 ]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 ]No smoking between the quit day and the follow-up measure.
- Time to 7-day relapse [ Time Frame: Week 52 ]
- Lapse & Recovery events [ Time Frame: Week 52 ]Timing and rates of lapses (smoking episodes not lasting 7 days) and recovery events (return to 24-hour abstinence).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756885
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Robert A Schnoll, PhD||University of Pennsylvania|