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Extended Varenicline Treatment for Smoking Among Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01756885
First received: December 20, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: Varenicline
Drug: Placebo
Behavioral: Smoking Cessation Counseling
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


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: 400
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)
Arms Assigned Interventions
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

Drug: Varenicline
Other Name: Chantix
Drug: 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

Drug: Varenicline
Other Name: Chantix
Behavioral: Smoking Cessation Counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Current cancer diagnosis (all sites) or diagnosis within the past 5 years.
  3. Karnofsky Score of >50 or ECOG Performance Status score of <2 within 6 months of enrollment.
  4. Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
  5. Residing in the geographic area for at least 12 months.
  6. 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.
  7. Able to communicate fluently in English.
  8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.

Exclusion Criteria:

Smoking Behavior

  1. Current enrollment or plans to enroll in another smoking cessation program in the next 12 months.
  2. Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
  3. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 12 months.

    1. 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

  1. Diagnosis of substance abuse or dependence that has been unstable in the past year.
  2. Positive urine drug screen (for cocaine, opioids, or methamphetamines) at the Intake Session (unless taking opiate for pain management).
  3. Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the Intake Session.
  4. 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:

  1. 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.

  2. Anti-psychotic medications.
  3. Bipolar Disorder medications.

Medical Exclusion Criteria

  1. Women who are pregnant, planning a pregnancy within the next 12 months, or lactating.
  2. History of epilepsy or seizure disorder (history of seizure requires Study Physician approval).
  3. History of kidney disease, including transplant.
  4. 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.

  5. History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval).
  6. Abnormal ECG (unless approved by Study Physician).
  7. Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or self-reported suicide attempt.
  8. Current or past diagnosis of psychotic or bipolar disorder, as determined by self-report & MINI.
  9. Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for >30 days).
  10. Previous allergic reaction to varenicline.

General Exclusion Criteria

  1. Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
  2. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
  Contacts and Locations
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

Contacts
Contact: Amanda M Kaufmann 215-746-8434 akau@mail.med.upenn.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Veluz-Wilkins, MA    312-503-3098    a-veluz-wilkins@northwestern.edu   
Principal Investigator: Brian Hitsman, PhD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Amanda M Kaufmann    215-746-8434    akau@mail.med.upenn.edu   
Principal Investigator: Robert A Schnoll, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Robert Schnoll, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01756885     History of Changes
Other Study ID Numbers: R01CA165001
Study First Received: December 20, 2012
Last Updated: August 12, 2014
Health Authority: 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:
Smoking cessation
Nicotine dependence
Varenicline
Chantix
Cancer

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014