Extended Varenicline Treatment for Smoking Among Cancer Patients
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Placebo; Smoking Cessation Counseling
Intervention description: Varenicline was used in accordance with FDA approved labeling: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).; On Day 85, participants randomized to standard therapy will be given placebo pills (resembling the 1.0mg pills),; Behavioral Counseling (from Week 0 - Week 18)
The counseling protocol was based on PHS guidelines for smoking cessation treatment (Fiore et al., 2008), used in our past studies with cancer patients (Schnoll et al., 2010a) and in our ongoing cessation trial at NU (R01 DA025078). Counseling is included given its efficacy at helping smokers quit (Fiore et al., 2008) and to increase study retention. Counseling is provided to both treatment arms through Week 18 to equate for time and attention across arms and since this method was used in varenicline clinical trials (Gonzales et al., 2006) and in our extended therapy trial (Schnoll et al., 2010b). In-person counseling was selected for most sessions to ensure adequate monitoring of participant safety and adherence throughout the trial.
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking cessation; Nicotine dependence; Varenicline; Chantix; Cancer

Summary:

      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.
    

Eligibility 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.