UW Quitting Using Intensive Treatment Study (QUITS)

Building on our recent NHLBI-funded publication in JAMA (1) that described the modest
effectiveness of varenicline pharmacotherapy, this study will use a 2 X 2 factorial design to
evaluate two different medication use strategies on their ability to markedly enhance
varenicline effectiveness in a large cohort of current smokers. Smokers (N=1000) will be
randomly assigned to one of two levels for each of two factors: 1) an Adjuvant factor
(varenicline + placebo patch versus varenicline + nicotine patch), and 2) a Duration factor
(12 versus 24 weeks of active medication). Thus, this factorial design yields a "standard"
varenicline treatment (12 weeks of active varenicline and 12 weeks of placebo varenicline +
24 weeks of placebo patch), and 3 enhanced treatments: 1) 12 weeks of active varenicline and
12 weeks of placebo varenicline + 24 weeks of active patch, 2) 24-weeks of active varenicline
+ 24 weeks of placebo patch, and 3) 24 weeks of active varenicline + 24 weeks of active
patch.

Both treatment modifications, longer duration therapy and use of a nicotine replacement
therapy (NRT) adjuvant, have produced some quite promising effects. However, in both cases
these modifications have been little researched, their effects are not consistently positive,
and they have not been implemented in a potentially optimal manner. We will implement each
modification in an innovative manner designed to enhance its effectiveness. In addition, all
participants will be given counseling that supports adherent medication use and that is
readily translatable to healthcare settings. The scientific rigor of this work will be
enhanced by the use of placebo medication, a large sample, and a factorial design. The latter
will allow us to test both the main and interaction effects of the experimental factors. We
will also be able to compare each enhanced treatment with standard 12-week varenicline-only
therapy to determine whether any of these medication use strategies significantly enhances
treatment effectiveness.

(1) Baker TB, Piper ME, Stein JH, Smith SS, Bolt DM, Fraser DL, Fiore MC. Effects of Nicotine
Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26
WeeksA Randomized Clinical Trial. JAMA. 2016;315(4):371-379

Inclusion criteria:

Participants must: plan to stay in the area for the next 12 months, ability to read and
write in English, smoke on average ≥5 cigarettes per day over the last 6 months, be ≥18
years old, desire to quit smoking but not be engaged currently in cessation treatment,
report no use of pipe tobacco, cigars, snuff, e-cigarettes or chew in the last 30 days,
have reliable phone access, willing and able to use both nicotine patch and varenicline,
access to transportation to come to our clinic and, if female, not be pregnant and be using
an acceptable birth control method/ method to prevent pregnancy. Smoking will be
biochemically confirmed via a carbon monoxide (CO) breath test at the orientation session
visit. Potential participants must have a CO test result of ≥5ppm for eligibility to
participate.

Exclusion criteria:

Current treatment for schizophrenia or a psychotic disorder; suicidal ideation in the past
12 months; history of suicidal attempts within the last 10 years; on dialysis or being told
you have severe kidney disease; hospitalization for a stroke, heart attack, congestive
heart failure or uncontrolled diabetes mellitus within the past year; history of seizure
within the last year; currently taking Wellbutrin, Zyban, or Buproprion (Contrave is a
weight-loss drug that has Wellbutrin in it) for reasons other than to quit smoking or
taking to help quit smoking and not willing to stop for duration of the study; currently
using any form of nicotine replacement (e.g., nicotine patch, nicotine gum, nicotine
lozenge) or using Chantix or varenicline and not willing to stop for duration of the study;
had a reaction to the nicotine patch that prevented them from continuing to use it; or
currently participating in another smoking cessation study.

Pregnancy:

Even though we screen out participants who are pregnant, plan to become pregnant, nursing,
or are unwilling to take steps to avoid pregnancy, there is a chance that a participant
eligible at consent could become pregnant later. She would then be considered part of a
vulnerable group. Given the longitudinal nature of the research, a participant who becomes
pregnant after enrolling will be given the choice of whether to 1) continue in the study
(for counseling and other assessments) and agree to immediately stop taking study meds for
the remaining duration of the study and return any unused medications, OR 2) withdraw. No
further medications will be given to this study participant while in the study.

Incarcerated Individuals:

Incarcerated individuals will not be enrolled in this study. However, given the
longitudinal nature of the research, participants could be incarcerated for periods during
their participation. If study staff learn that a participant is incarcerated at a time
point before or at their Week 8 phone call, the participant will be withdrawn from the
study. If study staff learn that a participant is incarcerated subsequent to Week 8, the
participant will not be withdrawn unless that incarceration will take them beyond the study
period. In that case, staff will not contact the participant while incarcerated and will
not provide any treatment (counseling or medication) nor conduct any assessments during the
period of incarceration. Services and assessments will be re-initiated if the participant
is released at a later study time point.