Extended Varenicline Treatment for Smoking Among Cancer Patients



Status:Completed
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:January 2013
End Date:May 31, 2018

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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.


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.
We found this trial at
2
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Robert A Schnoll, PhD
Phone: 215-898-9941
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Brian Hitsman, PhD
Phone: 312-503-3098
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Chicago, IL
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