Extended Varenicline Treatment for Smoking Among Cancer Patients
Verified November 2015 by University of Pennsylvania
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
First received: December 20, 2012
Last updated: November 30, 2015
Last verified: November 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial
Primary Outcome Measures:
Secondary Outcome Measures:
- 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).
Other Outcome Measures:
- 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).
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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: Chantix
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: Chantix
Behavioral: Smoking Cessation Counseling
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average, for the last 6 months.
- Current cancer diagnosis (all sites) or diagnosis within the past 5 years.
- Karnofsky Score of >50 or ECOG Performance Status score of <2 within 6 months of enrollment.
- Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
- Residing in the geographic area for at least 12 months.
- Women of childbearing potential (based on medical history and physical exam) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication and for at least one month after the medication period ends.
- Able to communicate fluently in English.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.
- Current enrollment or plans to enroll in another smoking cessation program in the next 12 months.
- Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 12 months.
- Note: Once participants are found eligible for the study, they are told they should refrain from using any nicotine replacement therapy (NRT) for the duration of the study. If a subject reports an isolated (non-daily) instance of NRT use during the study, they may be permitted to continue.
Alcohol/Drug Exclusion Criteria
- Diagnosis of substance abuse or dependence that has been unstable in the past year.
- Positive urine drug screen (for cocaine, opioids, or methamphetamines) at the Intake Session (unless taking opiate for pain management).
- Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the Intake Session.
- Current alcohol consumption that exceeds 25 standard alcoholic drinks/week.
Medication Exclusion Criteria
Current use or recent discontinuation (within last 14 days) of the following medications:
Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)
a. Note: Once participants are found eligible for the study, they are instructed to only use the smoking cessation medication provided to them by the study staff. If a subject reports an isolated (non-daily) instance of using a non-study smoking cessation medication, the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.
- Anti-psychotic medications.
- Bipolar Disorder medications.
Medical Exclusion Criteria
- Women who are pregnant, planning a pregnancy within the next 12 months, or lactating.
- History of epilepsy or seizure disorder (history of seizure requires Study Physician approval).
- History of kidney disease, including transplant.
Uncontrolled hypertension (SBP >160 or DBP >100).
a. Note: If a participant presents with blood pressure greater than 160/100 at sessions occurring on Week 0 (Pre-Quit) or at any other point during the treatment period, they will not be provided with/able to continue on medication unless the study physician grants approval.
- History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval).
- Abnormal ECG (unless approved by Study Physician).
- Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or self-reported suicide attempt.
- Current or past diagnosis of psychotic or bipolar disorder, as determined by self-report & MINI.
- Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for >30 days).
- Previous allergic reaction to varenicline.
General Exclusion Criteria
- Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756885
|Chicago, Illinois, United States, 60611 |
|Contact: Anna Veluz-Wilkins, MA 312-503-3098 email@example.com |
|Principal Investigator: Brian Hitsman, PhD |
|University of Pennsylvania
|Philadelphia, Pennsylvania, United States, 19104 |
|Contact: Sonja Blazekovic 215-898-9941 firstname.lastname@example.org |
|Principal Investigator: Robert A Schnoll, PhD |
University of Pennsylvania
||Robert A Schnoll, PhD
||University of Pennsylvania
||Robert Schnoll, Associate Professor, University of Pennsylvania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2012
||November 30, 2015
||United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by University of Pennsylvania:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 27, 2016
Tobacco Use Disorder
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs